197 Trackwise Jobs - Page 3

Position: Sr Executive / Manager Engineering - Instrumentation Grade: G11B / G11A No. of Position: 1 No. Job Location: Ahmednagar Qualification: B.E. (Instrumentation) Experience: 8 to 12 yrs experience in Engineering (Instrumentation) of API manufacturing plant Job Profile Initiation & Execution of brown field project related to Instrumentation & Automation. Distributed control system Installation, Commissioning and maintenance as well as trouble shooting in day-to-day routine activities. Installation, commissioning and maintenance of electrical MCC panel, PLC control panel & Remote I/O panel etc. Technical Specification finalization of DCS, SCADA System & instruments during procurement of equipment and control system. Coordination with cross fictional team as and when needed. Identify the critical equipment’s and maintained the critical spares. Installation, Commissioning and maintenance of centralized SCADA system and integrated with PLC of all dryer’s automation. Handling & maintenance of UPS & EPBAX system. Installation, Commissioning and maintenance of PLC & HMI based Automation for purified water system. Installation, Commissioning & maintenance of On-line monitoring & CCTV surveillance system in entire plant. Execution of Preventive, Breakdown and proactive Maintenance of equipment’s & Process Modification in the plant. Planning & execution of PLC /DCS Validation / Qualification for In-house & External Vendor audit as per cGMP. Attending the breakdown related to process and utility equipment. Handle SAP activities, Calibration of manufacturing activities etc. Handle QMS activities in Trackwise such as Change control, Deviations etc.in engineering department, to perform and support engineering related investigations. Co-ordinate and face the audits such as regulatory audit, statutory audits, safety audits etc. To take care of PCS related activities and to take care CSV Validation activities.

Why join Stryker? Looking for a place that values your unique talents? Discover Stryker's award-winning culture. We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific. Job description We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific. What will you do: Basic knowledge and understanding of complaint handling process as required by regulatory agencies. Provide updates within Trackwise on status of product field action executions and event detail information. Monitor and facilitate product return for complaint investigation and analysis, including communicating directly with customers and sales teams. May support international and domestic complaint entry. Work with internal supporting teams on quality of data coming into post market May monitor, create, and assign regulatory communications to quality specialists for resolution. What you will need: Basic Qualifications: Minimum 2 to 5 years relevant experience required Basic knowledge and understanding of complaint handling and product field action process as required by regulatory agencies Basic knowledge on Trackwise Basic understanding of how to comply with constantly changing regulatory procedures preferred Preferred Qualifications: Must possess strong interpersonal skills including written and oral communication. Must be able to bring tasks through to completion with minimal supervision. Must have the ability to prioritize work and keep detailed and confidential records. Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

Department CENTRAL QUALITY Job posted on Jul 14, 2025 Employment type C-C8-Confirmed-HO Executive Requirements: Candidate from CSV, Qualification, Micro background can apply. Qualification must be M. Pharma. JOB RESPONSIBILITES: Facilitate and track the quality software projects (cGMP software’s) including Lonza Moda, Trackwise, Document management software and Artwork management software. Familiar with the functionalities and applications of Lonza MODA for environmental monitoring. Ensure project requirement met timely and gets completed within the defined timeline. Ensure compliance of all the quality software’s as per 21 CFR, part 11. Conduct software validation activities in accordance with the validation master plan. Perform user acceptance testing (UAT) for the software and updates to the existing systems Coordinate with software developers for necessary upgrades and enhancements. Coordinate with IT, sites and other teams from corporate for the development, validation and implementation of various software. Prepare and maintain the documents related to all quality software. Develop and revise the standard operating procedures (SOPs) and policies related to software management. To prepare the documents related to all quality software’s. Impart operational training to core team members on use of Lonza Moda, Trackwise, Document management software and Artwork management software. Provide support to end users and troubleshooting assistance for software related queries. Perform any other tasks assigned by the HOD as and when required and support other initiatives.

HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Quality Specialist Live What You Will Do Let’s do this. Let’s change the world. In this vital role you will Support the R&D quality Audit and help to build quality into everything Amgen does. Data entry into Amgen’s Quality System of approved audit responses Audit resourcing/planning Quarterly Investigator Site audit planning including identifying audit resources through risk assessment of audit targets on a regular basis Yearly planning of other audit types including internal process/Service Provider and Affiliate Audits Updating Audit tracking and accountability tools and distributing/communicating allocations to the audit teams Compiling Audit reporting metrics and communication Manage Audit documentation and filing Supporting outsourced audits by: Supporting outsourced audit resourcing/planning for Audits Provide necessary tools, reports/documentation, and access to systems for outsourced Audits Review initial draft audit reports, audit responses and debrief slides. Schedule and facilitate Quality Lead (pre-audit meetings) and audit debrief meetings QC Data entry into AMS of audit findings Confirming data entry into RDCS of approved audit responses Oversee timelines met for issuance of Initial audit reports; review of audit responses and issuing Final Audit Reports Provide guidance and resolve queries from external Audit vendors Weekly Meeting with external audit vendor to review tasks and status of audits Communicate noncompliance to Manager Administrative Support (includes maintaining & updating distribution lists and templates) Data entry/QC in to the Audit Management System (Trackwise) of audit findings Administrative support for audit resourcing/planning Manages Audit documentation and filing Ensures that the Audit Archive is updated with Final audit reports and closure memos and Plans/Agendas where applicable Follow up with CAPA Owners for completion dates and objective evidence Review and Append Objective evidence in Amgen’s Quality System and close record What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek has a ‘can do’ approach with these qualifications. Basic Qualifications: Master’s degree in Life sciences or related field Preferred Qualifications: Minimum of 3-5 years in biopharmaceutical industry experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility. Experience supporting regulatory authority inspections of clinical research, and/or pharmacovigilance activities Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise. Quality Assurance Qualification/Certification (preferred)

Data Migration Engineer /Lead Position Overview: The Data Migration Lead Engineer will lead and execute data migration to Veeva Vault, ensuring data integrity and quality while developing strategies and mapping data from legacy systems. Key Responsibilities: Develop and lead data migration strategies for Veeva Vault from QMS (Caliber, Trackwise, homegrown), DMS (Biovia, Trackwise, Omnidocs), and LMS systems. Oversee end-to-end data migration processes, ensuring quality and integrity pre- and post-migration. Map master data elements from legacy to target systems with precision. Manage and mentor migration teams to achieve seamless execution. Ensure compliance with data migration standards and best practices. Qualifications: Proven experience migrating data to Veeva Vault from diverse QMS, DMS, and LMS systems. Expertise in data migration strategy development and execution. Strong skills in mapping master data elements across systems. Leadership and team management experience. Deep understanding of data integrity and quality assurance processes.

COMPUTER OPERTOR WITH FULLY KNOWLEDGE OF TALLY MAKING ENQUIRY , QUOTATION, INVOICE Operate and monitor computer systems and equipment. Perform routine maintenance and troubleshooting of computer hardware and software. Ensure the security and integrity of data and systems. Collaborate with IT staff to resolve technical issues. Maintain accurate records of computer operations and activities. Provide technical support and assistance to users. Stay updated with the latest advancements in computer technology.

Responsible for plant utilities operation and facilities maintenance (HVAC, electrical system, water system, infrastructure services) within regulatory guidelines and good engineering practice. Good knowledge of Water system operation (RO plant, EDI , PW loop, MGF and ozone system) as per Pharmaceutical requirement and WHO guideline. Good knowledge of Operation of screw air compressor, reciprocating air compressor and air dryer along with compressed air testing as per ISPE medical gases and ISO 8573 standards. Responsible for operation and maintenance of HVAC, Chiller, cooling tower and Hot water system. Knowledge of HVAC validation as per ISO guideline and other pharmaceutical requirement. Knowledge of plant maintenance in OSD pharmaceutical is preferred like Coating machine, RMG, Compression machine and FBP/FBD. Plan and support resources to operate utilities and ensure 24 X 7 continuous system operation to support plant activities. Ensure all time audit readiness by complying with effective standards, regulatory/statutory and cGMP requirement to protect product and prevent major compliance observation. Review and approve the utilities log sheets and work orders for compliance with quality requirement. Knowledge of QMS system like Trackwise, change control and SOP preparedness. Provide engineering support, organize and implement routine PM and yearly schedule shutdown. Train and develop maintenance employees, upgrade their capability continuously. Assist maintenance manager to ensure maintenance team compliant with GMP requirement. Establish spare part list and effective inventory level to ensure maximum equipment uptime of Utilities System. Manage operation and maintenance service contracts to ensure Utilities systems are operated and maintained in accordance with regulatory, quality, ESH and budgetary requirement to sustain safe, reliable and efficient utilities operations. Lead/Participate in discrepancy management process, identify root cause, implement corrective & preventive measures and drive records for timely closure. Ensure CAPA is in place for any deviations to prevent future recurrence incident. Support Engineering, site expansion and other and projects. Undertake tasks assigned by leaders as and when appropriate

Responsible for plant utilities operation and facilities maintenance (HVAC, electrical system, water system, infrastructure services) within regulatory guidelines and good engineering practice. Good knowledge of Water system operation (RO plant, EDI , PW loop, MGF and ozone system) as per Pharmaceutical requirement and WHO guideline. Good knowledge of Operation of screw air compressor, reciprocating air compressor and air dryer along with compressed air testing as per ISPE medical gases and ISO 8573 standards. Responsible for operation and maintenance of HVAC, Chiller, cooling tower and Hot water system. Knowledge of HVAC validation as per ISO guideline and other pharmaceutical requirement. Knowledge of plant maintenance in OSD pharmaceutical is preferred like Coating machine, RMG, Compression machine and FBP/FBD. Plan and support resources to operate utilities and ensure 24 X 7 continuous system operation to support plant activities. Ensure all time audit readiness by complying with effective standards, regulatory/statutory and cGMP requirement to protect product and prevent major compliance observation. Review and approve the utilities log sheets and work orders for compliance with quality requirement. Knowledge of QMS system like Trackwise, change control and SOP preparedness. Provide engineering support, organize and implement routine PM and yearly schedule shutdown. Train and develop maintenance employees, upgrade their capability continuously. Assist maintenance manager to ensure maintenance team compliant with GMP requirement. Establish spare part list and effective inventory level to ensure maximum equipment uptime of Utilities System. Manage operation and maintenance service contracts to ensure Utilities systems are operated and maintained in accordance with regulatory, quality, ESH and budgetary requirement to sustain safe, reliable and efficient utilities operations. Lead/Participate in discrepancy management process, identify root cause, implement corrective & preventive measures and drive records for timely closure. Ensure CAPA is in place for any deviations to prevent future recurrence incident. Support Engineering, site expansion and other and projects. Undertake tasks assigned by leaders as and when appropriate In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.

Be the First to Apply Job Description Responsible for plant utilities operation and facilities maintenance (HVAC, electrical system, water system, infrastructure services) within regulatory guidelines and good engineering practice. Good knowledge of Water system operation (RO plant, EDI , PW loop, MGF and ozone system) as per Pharmaceutical requirement and WHO guideline. Good knowledge of Operation of screw air compressor, reciprocating air compressor and air dryer along with compressed air testing as per ISPE medical gases and ISO 8573 standards. Responsible for operation and maintenance of HVAC, Chiller, cooling tower and Hot water system. Knowledge of HVAC validation as per ISO guideline and other pharmaceutical requirement. Knowledge of plant maintenance in OSD pharmaceutical is preferred like Coating machine, RMG, Compression machine and FBP/FBD. Plan and support resources to operate utilities and ensure 24 X 7 continuous system operation to support plant activities. Ensure all time audit readiness by complying with effective standards, regulatory/statutory and cGMP requirement to protect product and prevent major compliance observation. Review and approve the utilities log sheets and work orders for compliance with quality requirement. Knowledge of QMS system like Trackwise, change control and SOP preparedness. Provide engineering support, organize and implement routine PM and yearly schedule shutdown. Train and develop maintenance employees, upgrade their capability continuously. Assist maintenance manager to ensure maintenance team compliant with GMP requirement. Establish spare part list and effective inventory level to ensure maximum equipment uptime of Utilities System. Manage operation and maintenance service contracts to ensure Utilities systems are operated and maintained in accordance with regulatory, quality, ESH and budgetary requirement to sustain safe, reliable and efficient utilities operations. Lead/Participate in discrepancy management process, identify root cause, implement corrective & preventive measures and drive records for timely closure. Ensure CAPA is in place for any deviations to prevent future recurrence incident. Support Engineering, site expansion and other and projects. Undertake tasks assigned by leaders as and when appropriate Responsibilities Key Roles/Responsibilities: To raise purchase requisition for spares and required material in consultation with engineering manager. To identify consumables and frequently used spare for each machine and plan in coordination engineering manager for inventory of such spares. To check and approve incoming engineering goods. To ensure legal/statutory compliance related to utility equipment. To execute and complete project, area renovation work within scheduled timeframe. To identify area of energy conservation and take operational and technological measures for efficient utilization of energy. To maintain low engineering costs & ensure they remain with reasonable variance of sanctioned budget. Qualifications Education :- B.E. / B. Tech Mechanical Engg. Required Skills Good Communication Skill & Time Management About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide. Job Info Job Identification 9075 Job Category Engineering Posting Date 07/10/2025, 02:20 PM Degree Level Bachelor's Degree Job Schedule Full time Locations Plot No:-19,PHARMEZ, Sarkhej-Bawala NH-8A, Ahmedabad, Gujarat, 362001, IN

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.

Job Description Responsible for plant utilities operation and facilities maintenance (HVAC, electrical system, water system, infrastructure services) within regulatory guidelines and good engineering practice. Good knowledge of Water system operation (RO plant, EDI , PW loop, MGF and ozone system) as per Pharmaceutical requirement and WHO guideline. Good knowledge of Operation of screw air compressor, reciprocating air compressor and air dryer along with compressed air testing as per ISPE medical gases and ISO 8573 standards. Responsible for operation and maintenance of HVAC, Chiller, cooling tower and Hot water system. Knowledge of HVAC validation as per ISO guideline and other pharmaceutical requirement. Knowledge of plant maintenance in OSD pharmaceutical is preferred like Coating machine, RMG, Compression machine and FBP/FBD. Plan and support resources to operate utilities and ensure 24 X 7 continuous system operation to support plant activities. Ensure all time audit readiness by complying with effective standards, regulatory/statutory and cGMP requirement to protect product and prevent major compliance observation. Review and approve the utilities log sheets and work orders for compliance with quality requirement. Knowledge of QMS system like Trackwise, change control and SOP preparedness. Provide engineering support, organize and implement routine PM and yearly schedule shutdown. Train and develop maintenance employees, upgrade their capability continuously. Assist maintenance manager to ensure maintenance team compliant with GMP requirement. Establish spare part list and effective inventory level to ensure maximum equipment uptime of Utilities System. Manage operation and maintenance service contracts to ensure Utilities systems are operated and maintained in accordance with regulatory, quality, ESH and budgetary requirement to sustain safe, reliable and efficient utilities operations. Lead/Participate in discrepancy management process, identify root cause, implement corrective & preventive measures and drive records for timely closure. Ensure CAPA is in place for any deviations to prevent future recurrence incident. Support Engineering, site expansion and other and projects. Undertake tasks assigned by leaders as and when appropriate Responsibilities Key Roles/Responsibilities: To raise purchase requisition for spares and required material in consultation with engineering manager. To identify consumables and frequently used spare for each machine and plan in coordination engineering manager for inventory of such spares. To check and approve incoming engineering goods. To ensure legal/statutory compliance related to utility equipment. To execute and complete project, area renovation work within scheduled timeframe. To identify area of energy conservation and take operational and technological measures for efficient utilization of energy. To maintain low engineering costs & ensure they remain with reasonable variance of sanctioned budget. Qualifications Education :- B.E. / B. Tech Mechanical Engg. About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.

Education Graduation in Pharmacy Long Description The person should have knowledge in Manufacturing equipments. He should have exposure in equipment’s such as FBE,Fette/KORSCH M/C & auto coater M/C He should be able to handle equipment trouble shoot in Manufacturing department. He should have exposure in regulatory organization . He must have faced the USFDA ,MHRA & other regulatory audits. He should have the exposure in Caliber QAMS, elog, track wise ,SAP ,WIND ,CDAS & other software. He should have the exposure in process simplification/optimization ,SABA ,elog & SCADA. Competencies Work Experience 3-6 years work experience in Fette compression machine

Educational Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to:6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM.Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.Stakeholder management and good executor with required communication.Candidate must have fair conceptual understanding on below key areasoIT QMSoValidation/QualificationoRisk management. oHandling of defects/Deviations oInvestigations oCAPA Handling oTest Management & Compliance Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc. Technical and Professional : Hands-on experience on testing tools like HP ALM, Kneat and SNOW-Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage -OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)-PAS/DCS Qualification -ISA95 High level of understanding -OT Security will be a plus.-Standalone Systems Qualifications-PAS/DCS Integrated with Manufacturing Equipment qualification. Preferred Skills: LS Domain-Computer System Validation (CSV)

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –LIMS Consultant - Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in LIMS Implementations & Configurations for Life Sciences industries to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS requirements. Gather and analyse business requirements related to LIMS functionality and enhancements. Analyse laboratory workflows and processes to recommend and implement LIMS solutions. Translate business needs into functional specifications and system configurations. Configure, test, and validate LIMS functionalities to meet business needs. Conduct impact analysis and risk assessments for LIMS changes and enhancements. Serve as a liaison between business users and technical teams to ensure effective communication and system alignment. Participate in business process mapping and workflow optimization to enhance LIMS utilization. Provide input on LIMS enhancements and new feature development to improve system performance. Assist in troubleshooting, identifying, and resolving LIMS-related issues. Conduct user training sessions and provide end-user support. Work with laboratory teams to ensure LIMS supports laboratory practices, procedures, and workflows effectively. Identify opportunities for automation and process improvement within laboratory operations using LIMS. Master Data Design Configuration Analyse the Technical documents such as SOP/STP/Monograms/Pharmacopeial references and convert them into LIMS compatible data sets. Configure master data elements such as test methods, sample types, specifications, workflows, and stability studies within LIMS. Maintain data integrity, consistency, and version control across the system. Implement changes and updates to LIMS master data in alignment with business and regulatory needs. Collaborate with cross-functional teams to ensure accurate data migration and system integration. Troubleshoot and resolve issues related to master data configuration and system functionality. Work on optimizing data structures and database management within LIMS. Configurations & Customizations Develop, customize, and implement LIMS applications to meet laboratory and business requirements. Configure, extend, and support LabWare LIMS, LabVantage LIMS, and other LIMS platforms. Integrate LIMS with other enterprise systems such as ERP, ELN, CDS, MES, and laboratory instrumentation software. Design and optimize databases for efficient storage and retrieval of laboratory data. Develop and maintain system interfaces, workflows, and automation scripts to streamline laboratory processes. Provide technical support, troubleshooting, and bug fixes for LIMS applications, ensuring minimal downtime. Collaborate with laboratory personnel, IT teams, and stakeholders to enhance system functionality and usability. Create and maintain system documentation, including user guides, SOPs, validation protocols, and technical specifications. Ensure compliance with industry standards such as CGxP, PICS, FDA 21 CFR Part 11, EU GMP Annex 11 etc. Stay up to date with new LIMS technologies, trends, and best practices. Ensure system security, access control, and compliance with IT policies. Provide ongoing support and maintenance for LIMS applications. Engage in change management processes and drive adoption of new system functionalities. Work with vendors and third-party providers to Configure, implement upgrades and enhancements. Demonstrate teamwork by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Strong understanding of laboratory workflows, sample lifecycle management, and data integrity principles. Familiarity with analytical techniques, laboratory instrumentation, and regulatory standards. Exposure to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and ISO 17025 compliance. Experience in working with scientific and analytical teams to align LIMS functionality with laboratory operations. Understanding of quality control, stability studies, environmental monitoring, and batch release processes within laboratories. Proficiency in LIMS software (e.g., LabWare, LabVantage, STARLIMS, SampleManager, or similar platforms). Knowledge of system integration with ERP, MES, or other enterprise applications. Previous experience as a Business Analyst or System Administrator or Master Data Manager working with LIMS. Hands-on experience in master data configuration within LIMS platforms. Experience in system validation, testing, and documentation. Exposure to Enterprise IT applications like ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, etc. in Pharmaceutical organization Understanding of relational databases and SQL queries. Experience with scripting or automation tools for LIMS is a plus. Understanding of API integrations, web services, and middleware solutions for LIMS. Ability to troubleshoot system and data issues efficiently. Strong problem-solving and analytical skills. Excellent communication and stakeholder management abilities. Ability to work independently and as part of a cross-functional team. Strong attention to detail and commitment to data integrity. Adaptability to dynamic business and regulatory environments. Demonstrated track record in project management, governance, and reporting Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management. Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Comp. Science/ Life Sciences/Chemistry/Information Technology or a related field)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 4-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies or Leading Life sciences / Pharmaceutical Industries. Good interpersonal skills; Good written, oral and presentation skills Ideally, you’ll also have Information Security (ISO 27001) or Risk Management certifications LIMS admin certification or Equivalent Certified Scrum Master (CSM) or Equivalent (Preferred but not required). What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.

Company Description Epitome Components Limited is a leading PCB manufacturer based in India with advanced infrastructure and a large production capacity of 100,000 sqm per month. We have a satisfied customer base throughout India and abroad, including leading companies such as Videocon, LG, Nokia, Thomson, Philips, and Pricol. Epitome has formed a joint venture with UK-based Trackwise Designs Ltd. to manufacture RF Antenna PCBs for cellular networks, radar, space industry, and various high-end applications. Role Description This is a full-time on-site role for a Sales Executive located in Supa Ahmednagar. Responsible for developing a sales plan. organizing sales visits Demonstrating and presenting products. negotiating contracts and packages aiming to achieve monthly or annual targets Team handling, guiding team members in the right way. Business Development, Achieving the target by managing the Sales Training, distribution, and achievement of targets, Maintenance/Service and new acquisition of customers, Planning and formulating new and innovative sales & marketing strategies to promote sales. Participating in critical Sales/ relationship calls & acquires prospective customers. Handling company’s daily transportation incoming and outgoing of the materials. Handling the new inquiry of customers for new orders. To solve the problems of the customers by co-coordinating with the production/Quality. Qualifications Strong communication and interpersonal skills Proven ability to meet and exceed sales targets Experience in preparing sales reports and conducting market research Knowledge of PCB manufacturing and high-end applications is a plus Bachelor's degree in Business, Marketing, or a related field Ability to work independently as well as collaboratively within a team

Job Title Risk Management Engineer Job Description Risk Management Engineer In this role, you have the opportunity to make life better Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most. The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs. Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So in this role of Complaint Investigator, you share our passion for helping others, you’ll be working towards improving people’s live by improving product and patient safety. You are responsible for: Responsibility #1: 5+ years working knowledge of ISO 14971 and product specific regulations and standards. 3+ years working experience in a regulated industry. Ensures product safety risk management deliverables are created, maintained, and stored in the Risk Management file during product development. Ensures the appropriate safety risk assessments are performed when triggers are met and conducts product risk assessments as needed after product launch. Defend Risk Management and design quality activities during external and internal audits. Perform periodic reviews of Risk Management Files and ensure those are performed according to schedule. Evaluate process and product changes for their impact on the current Risk Management Files. Responsibility #2: Monitor post product data (e.g. Complaints, Corrective and Preventive Actions (CAPA), Non-conformance Reports (NCRs), Customer Feedback information, etc.) for impact to the Risk Management Files Coordinates with a cross functional team including Engineering and Medical Affairs in the creation and maintenance of the deliverables listed above. Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction. Ensures that all products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers in the Business. Responsibility #3: Introduce and implement complaint handling processes and tools required to ensure global regulatory compliance, quality, and patient safety. Manages compliance to FDA regulations and other Regulatory Agencies as required. Manages the oversight and review of complaint handling files, adverse event reports, regulatory inquiry responses, and safety escalations. Actively participates in inspections and questions relating to the operation of complaint handling operations, processes, and procedures in coordination with all other applicable company groups. Responsibility #4: Communicates performance feedback to individuals performing complaint handling activities, ensuring consistency, quality, and adherence to defined processes related to complaint handling, adverse event reporting, and safety escalations. Provides expert consultation to individuals responsible for the coordination and preparation of responses to regulators and competent authority inquiries when needed. Provides expert consultation and communicates decision making related to escalated issues for complaint handling activities, regulatory reporting decisions, requirements for additional investigation, and subject matter expert engagement. Engages with individuals within the Businesses, Markets, and Services organization to ensure the required information for complaint handling, regulatory reporting, and/or escalations for further investigation or action are communicated and acted upon. Responsibility #5: Develops and presents materials describing complaint handling and regulatory reporting KPIs, metrics, and/or daily management information to business, market, and leadership. Facilitates conversations with technical experts to ensure timely completion of escalations. (Technical investigations, IIAs, CAPAs) Support audits for complaint handling You will be part of You will be part of the Quality Team in Electronic Medical Records & Care Management Business. You will be able to partner with other experienced Quality team members and Leadership that will support you in the upcoming challenges and goals, and you will be able to join a very organized area where the teamwork is very much valued. To succeed in this position, you need to have the following expertise and experience: Bachelor degree in bio-medical, engineering, healthcare, or related technical degree with 8+ years of experience; OR Bachelor degree with 8+ years of experience in a medical device or regulated industry. Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), EUMDR, Canadian Medical Devices Regulation (SOR/98- 282), Japanese MHLW Ordinance 169, and ISO 9001. ISO14971 Risk Management, CAPA, Previous experience in Medical device. Product Knowledge is preferred. Project Management certificates(preferred). Mandatory: Working Knowledge in the area of Complaint Handling, Vigilance reporting and its global timelines and Post Market Surveillance (PMS) for medical products. Preferable: Knowledge of software product development, knowledge in Trackwise tool and/or Service tools. Knowledge of analytics tool/KPI trackers/Daily managements etc.. Detailed oriented, work allocation and monitoring, good communication skills, mentoring, team management, conflict management, team dynamics, self-starter, results, and targets oriented, resilience. Advanced English required (Oral and Writing) In return, we offer you At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2030, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy, respiratory care and services. How We Work At Philips Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. Our hybrid working model is defined in 3 ways: We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving. We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips? Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us. Job Description Analyst – Order Management Location: Bangalore – Electronic City Your Role Work as a team to support Process Solutions organization of Company’s LS to achieve the goal. Process service complaints in Trackwise and ERP. Hands on experience in ERP system SAP, Oracle and CRM tool SFDC. Knowledge of order management process and the concept of creating debit & credit. Partner with team to deliver quality services, enhance operational efficiencies. Customer focused approach. Process customer documentation requests. Process Leads in SFDC. Contribute to incremental revenue directly or indirectly. Essential Job Functions Complaint management – Handling service complaints. Create & assign Leads for Sales and Marketing team by critical thinking. Provide documentation support to customer using multiple tools. Create orders in ERP/other tools for credit, debit, investigation and return and establish the strong follow ups with key partners to close the requests in SFDC. Coordinating with Customer master data team to update customer masters. Process on discrepancy area database request and quality task request in ERP system. Creating and updating standard operating procedures for the process. Identifying and giving training on process to the team. Should work as a unit of the team to deliver daily set goals and achieve set TAT and quality. Recommend and participate in process improvement studies. Review of errors done by team and giving suggestion to mitigate the future occurrence. Build robust relationship with key partners and stakeholders. Attending review meetings with stakeholders where necessary. Exemplary attendance and adherence to schedule. Work on Adhoc requests when assigned. Establish Company’s values through daily operations. Should process orders and assist customer queries as per the region with the set expectation. Who You Are Any Bachelor’s Degree from recognized university. Preferably with relevant experience in SFDC, SAP, Oracle. Experience in Order Management / Service Complaints with 1-2 experience is preferred. Should possess basic knowledge of SFDC Functional Knowledge and ERP (SAP & Oracle) User Knowledge. Hands-on experience on ERP’s like SAP, Oracle SFDC Understand the basics of the Marketing Business knowledge and should be quick learner. Should possess basic knowledge of Microsoft Office (Word, Excel, PowerPoint). Technical Knowledge related to documentation. Effective follow up of the requests. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team!

Job Title Risk Management Engineer Job Description Risk Management Engineer In this role, you have the opportunity to make life better Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most. The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs. Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So in this role of Complaint Investigator, you share our passion for helping others, you’ll be working towards improving people’s live by improving product and patient safety. You are responsible for: · Responsibility #1: 5+ years working knowledge of ISO 14971 and product specific regulations and standards. 3+ years working experience in a regulated industry. Ensures product safety risk management deliverables are created, maintained, and stored in the Risk Management file during product development. Ensures the appropriate safety risk assessments are performed when triggers are met and conducts product risk assessments as needed after product launch. Defend Risk Management and design quality activities during external and internal audits. Perform periodic reviews of Risk Management Files and ensure those are performed according to schedule. Evaluate process and product changes for their impact on the current Risk Management Files. Responsibility #2: Monitor post product data (e.g. Complaints, Corrective and Preventive Actions (CAPA), Non-conformance Reports (NCRs), Customer Feedback information, etc.) for impact to the Risk Management Files Coordinates with a cross functional team including Engineering and Medical Affairs in the creation and maintenance of the deliverables listed above. Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction. Ensures that all products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers in the Business. · Responsibility #3: Introduce and implement complaint handling processes and tools required to ensure global regulatory compliance, quality, and patient safety. Manages compliance to FDA regulations and other Regulatory Agencies as required. Manages the oversight and review of complaint handling files, adverse event reports, regulatory inquiry responses, and safety escalations. Actively participates in inspections and questions relating to the operation of complaint handling operations, processes, and procedures in coordination with all other applicable company groups. · Responsibility #4: Communicates performance feedback to individuals performing complaint handling activities, ensuring consistency, quality, and adherence to defined processes related to complaint handling, adverse event reporting, and safety escalations. Provides expert consultation to individuals responsible for the coordination and preparation of responses to regulators and competent authority inquiries when needed. Provides expert consultation and communicates decision making related to escalated issues for complaint handling activities, regulatory reporting decisions, requirements for additional investigation, and subject matter expert engagement. Engages with individuals within the Businesses, Markets, and Services organization to ensure the required information for complaint handling, regulatory reporting, and/or escalations for further investigation or action are communicated and acted upon. · Responsibility #5: Develops and presents materials describing complaint handling and regulatory reporting KPIs, metrics, and/or daily management information to business, market, and leadership. Facilitates conversations with technical experts to ensure timely completion of escalations. (Technical investigations, IIAs, CAPAs) Support audits for complaint handling You will be part of You will be part of the Quality Team in Electronic Medical Records & Care Management Business. You will be able to partner with other experienced Quality team members and Leadership that will support you in the upcoming challenges and goals, and you will be able to join a very organized area where the teamwork is very much valued. To succeed in this position, you need to have the following expertise and experience: Bachelor degree in bio-medical, engineering, healthcare, or related technical degree with 8+ years of experience; OR Bachelor degree with 8+ years of experience in a medical device or regulated industry. Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), EUMDR, Canadian Medical Devices Regulation (SOR/98- 282), Japanese MHLW Ordinance 169, and ISO 9001. ISO14971 Risk Management, CAPA, Previous experience in Medical device. Product Knowledge is preferred. Project Management certificates(preferred). Mandatory: Working Knowledge in the area of Complaint Handling, Vigilance reporting and its global timelines and Post Market Surveillance (PMS) for medical products. Preferable: Knowledge of software product development, knowledge in Trackwise tool and/or Service tools. Knowledge of analytics tool/KPI trackers/Daily managements etc.. Detailed oriented, work allocation and monitoring, good communication skills, mentoring, team management, conflict management, team dynamics, self-starter, results, and targets oriented, resilience. A dvanced English required (Oral and Writing) In return, we offer you At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2030, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy, respiratory care and services. How we work at Philips Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. Our hybrid working model is defined in 3 ways: We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving. We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips? Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Job Purpose: To ensure effective and timely management of product complaints by receiving, documenting, investigating, analyzing, and resolving product-related complaints in compliance with applicable regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, MDR). The role supports continuous improvement of product quality and customer satisfaction. Key Responsibilities: Receive and log product complaints from customers, sales team, or regulatory bodies in the complaint management system. Acknowledge receipt of complaints and communicate resolution timelines to complainants. Evaluate the complaint to determine if it qualifies as a reportable event per regulatory requirements. Coordinate with cross-functional teams (R&D, Quality, Manufacturing, etc.) to investigate root cause(s). Ensure timely and accurate completion of complaint investigations, CAPA initiation (if required), and closure within defined timelines. Document complaint details, investigation findings, corrective actions, and outcomes. Communicate findings and resolutions to stakeholders and customers. Generate monthly/quarterly complaint trend reports and risk assessments. Support external/internal audits and regulatory inspections by providing complaint-related documentation. Maintain compliance with company SOPs, ISO standards, and regulatory requirements. Recommend preventive actions and contribute to quality improvement initiatives. Required Qualifications and Skills: Bachelor’s degree in Pharmacy, Science, Biomedical Engineering, or equivalent field. 3+ years of experience in product complaint handling, preferably in the medical device or pharmaceutical industry. Knowledge of ISO 13485, FDA regulations, MDR, and other global regulatory requirements. Strong analytical, problem-solving, and documentation skills. Familiarity with complaint management software or QMS tools (e.g., TrackWise, MasterControl, etc.). Excellent communication skills – written and verbal. Attention to detail and a commitment to quality and compliance. Preferred Qualifications: Certification in Quality Management Systems or Regulatory Affairs. Experience in root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA). Exposure to CAPA, NC, and audit handling processes.

Purpose of the Role The Senior Salesforce Administrator is responsible for supporting the overall maintenance of the Salesforce platform. Acting as a central point of orchestration for developers, support teams, as well as end users, the administrator provides critical day to day support for deployment, user setup, data, monitoring, troubleshooting, enhancing, automating, reporting, upgrading and training of the platform. The Admin will also act as a first level SME for the Complaint Handling Process within the Trackwise system Primary Duties and Responsibilities Own the end to end administration of the Salesforce Platform including user management, workflows, and basic validations. Deployment of platform changes, by collaborating with the global platform, application development & support teams Provide expert support with setup and maintenance of reports and dashboards Plan and manage release & upgrade of environments covering Salesforce Seasonal Releases, Trackwise Releases & Regular Change Requests Perform data load activities on demand Support MDR & other Regulatory/Compliance related activities Collaborate with offshore support teams to manage incidents , change requests & integrations Supervision of incidents , change requests & integrations collaborating with the external vendor teams Competencies Development Support: Support new developer onboarding activities Release Execution: Responsible to execute releases from SF, Trackwise & Olympus changes. Issue Resolution: Troubleshoot and resolve complex technical issues in collaboration with development teams and vendor support. Support Key Users and manage their delegated administration Administration of DevOps Infrastructure, Sandbox Management (clone, refresh, etc) & related access Security Review: Support regular security review activities by extracting the relevant reports and working with the Application owner Minimum Qualification Education*: Bachelor’s Degree in IT or Engineering or Computer Applications Experience*: Certified in Salesforce Administration 3+ years in Salesforce Administration & DevOps activities 2+ years with Trackwise or a similar Quality Management System. Skills: Good knowledge of Salesforce architecture and related technologies Good knowledge on SF development best practices, objects Experience with Agile/Scrum Techniques and tools like JIRA. Strong communication (verbal/written/listening) skills. Good organizational skills with an eye for detail and able to work within a team setting. Experience working with and/or driving remote teams across continents and time zones is a huge benefit.

Date: 30 Jun 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Essential Functions Role: Lead Maintenance Engineer Job Location: Bangalore Department: Engineering & Maintenance About Syngene: Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation. Job Purpose: Leading EAM team & activities at SU3. Execute maintenance and Upgradation projects. Ensures Safety & GMP compliance at SU3. Common Responsibilities Responsible for EAM activities in the Biologics Operations Unit Ensuring all assigned mandatory trainings related to data integrity, health and safety measures are completed on time. Develop and contribute to development of procedures, practices and setup that ensures safety operations compliant to company and regulatory norms. Specific Responsibilities Leading engineering and maintenance team for GMP areas at Biologics Manufacturing and Biologics Process Development. Able to handle minor project, design review and execute and Facility modification in a GMP facility. Exposure in handling Process, Electrical, HVAC, Utilities and instrumentation teams. Ensuring the related facility, equipment and maintenance systems are in GMP compliance state. Adherence to established procedures and policies of the company on Quality and Safety, ensuring the team adheres the same. Responsible for managing maintenance activities within framework of Quality management systems. Ensuring work management through defined SOP’s, Change control, deviations and CAPA, review and approval through Trackwise and EDMS. Represent the function during audits and ensuring agreed actions are acted upon timely. Ensure followings are complying: Equipment master list, Preventive Maintenance and calibration planners are prepared timely. Preventive maintenance and Calibration of equipment and facility are executed as per the planner. Qualification of equipment and facility and area validation for GMP blocks as per schedule. Operations and maintenance of Utilities to enable operations Service contracts for equipment and Instruments are planned and executed. Ensure that team comprising of on-roll engineers and contract manpower are trained on GMP requirements. Evaluation, assessment and selection of vendors for providing services for maintenance, calibration and validation Overall maintenance management that includes handling unscheduled breakdowns and other general upkeep activities are as per requirement to enable operations. Identifying and maintaining Inventory of equipment spares required for maintaining continuous operations. Reviewing and analysing the energy and utility consumption like electricity units, water etc. and take measures for control. Implementing the energy saving initiatives. Facility design, detail engineering and execution of any new requirements for business growth. Preparing and presenting the MIS reports Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company procedures, internal and external customers with respect to quality, service, lead time and cost. Good exposure in Regulatory audit handling. Educational Qualification: BE/BTech in Mechanical or Electirical or Instrumentation. Technical/functional Skills Responsible for EAM activities in the Biologics Operations Unit Ensuring all assigned mandatory trainings related to data integrity, health and safety measures are completed on time. Develop and contribute to development of procedures, practices and setup that ensures safety operations compliant to company and regulatory norms. Leading engineering and maintenance team for GMP areas at Biologics Manufacturing and Biologics Process Development. Able to handle minor project, design review and execute and Facility modification in a GMP facility. Ensuring the related facility, equipment and maintenance systems are in GMP compliance state. Experience: 15 years or above within Biologics manufacturing plant, with at-least 6-7 years of experience in Leading Engineering team, Projects & Maintenance. Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.