197 Trackwise Jobs - Page 2

Job Title: TrackWise Developer Job Summary: We are looking experienced TrackWise Developers to support system enhancements, integrations, and upgrades for TrackWise On-Prem environments. Key Responsibilities: Design and configure TrackWise On-Prem enhancements, forms, and workflows Integrate TrackWise with external systems using interfaces/web services Support upgrades, patches, and performance tuning of the system Troubleshoot system issues and ensure data integrity and compliance Create documentation and provide user support and training Collaborate with QA, IT, and business stakeholders on solution delivery Essential Technical Skills: TrackWise On-Prem Development & Configuration TrackWise Integration Projects (Interfaces, Web Services) XML / XSLT (TrackWise form customization) Certifications (Preferred): Sparta Systems TrackWise Certification ITIL Foundation

Supplier quality management. Drafting of Annual Monitoring and Certification report for materials. Drafting and Archival of Quality Assurance Agreement with Suppliers/Service providers Evaluation and Management of Supplier Change Notifications (SCN). Performing Quality Risk Assessment (QRA) for existing and new Suppliers / Service providers. Management of Supplier/ Material qualification and supplier related documentations. Preparation of regulatory statement for materials and finished products. Revision of Swiss Hub product list. Management of Import Licenses. Implementation and closure of Trackwise Change control actions related to Quality Assurance Agreements. Management and archival of Quality Questionnaires, QAA, QRA and Compliance (ASL, Oversight monitoring) for Country Quality. Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! The future is ours to shape!

Job Description Supplier quality management. Drafting of Annual Monitoring and Certification report for materials. Drafting and Archival of Quality Assurance Agreement with Suppliers/Service providers Evaluation and Management of Supplier Change Notifications (SCN). Performing Quality Risk Assessment (QRA) for existing and new Suppliers / Service providers. Management of Supplier/ Material qualification and supplier related documentations. Preparation of regulatory statement for materials and finished products. Revision of Swiss Hub product list. Management of Import Licenses. Implementation and closure of Trackwise Change control actions related to Quality Assurance Agreements. Management and archival of Quality Questionnaires, QAA, QRA and Compliance (ASL, Oversight monitoring) for Country Quality. Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! The future is ours to shape!

Lodha Group is looking for Data Analyst (Pre-Sales) to join our dynamic team and embark on a rewarding career journey Managing master data, including creation, updates, and deletion. Managing users and user roles. Provide quality assurance of imported data, working with quality assurance analysts if necessary. Commissioning and decommissioning of data sets. Processing confidential data and information according to guidelines. Helping develop reports and analysis. Managing and designing the reporting environment, including data sources, security, and metadata. Supporting the data warehouse in identifying and revising reporting requirements. Supporting initiatives for data integrity and normalization. Assessing tests and implementing new or upgraded software and assisting with strategic decisions on new systems. Generating reports from single or multiple systems. Troubleshooting the reporting database environment and reports. Evaluating changes and updates to source production systems. Training end-users on new reports and dashboards. Providing technical expertise in data storage structures, data mining, and data cleansing.

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story. We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee. At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact. Requirement Education/Training Bachelor’s degree in pharmacy. Work Experience Minimum six years’ experience in the pharma industry, acquired in Quality Assurance departments. Experience in pharmaceuticals, cosmetics and medical device Good skill and experience for handling of customer complaints, Deviation and QMS management. Be familiar with GDP, ISO9001, ISO13485 requirements and internal audit. Well verse with Excel, MS Word & Powerpoint, Trackwise, PATH & eDMS Required Pre-requisites Skills For This Position awareness of the local regulatory Guidelines and Corporate Standards and applicable laws, Expert in presentation preparation & delivery Analytical skills Good, positive and proactive communication skills, English. commitment to continued improvement in department processes and performance. Duties and Responsibilities Main Responsibilities Designated as Responsible Person (RP) for ensuring Good Distribution Practice (GDP) in complied with for products imported and wholesaled by Affiliate. GMP responsible person for the Affiliate as applicable Handling of customer complaints, processing the case in Trackwise and work / ensure compliance in accordance with respective SOP. Perform quality and compliance specific tasks including but not limited to end to end management of customer complaints, lias with customer care teram, internal stake holders , review of information about secondary packaging/redressing, ensure proper labelling of products at the distributor, and product recall coordination. Participate in the creation/update of local SOPs to reflect local practices in accordance with Corporate Policies and SOPs Implementing and maintaining the QMS to ensure that required processes are established and effective. Support in quality systems processes such as, but not limited to; internal audits/self-inspection, change control, management reviews, 3rd party vendor management, deviation management and CAPA Compile and update training manuals, undertake induction training and refresher training related to QMS for local affiliate staff Maintenance, analysis and reporting of Quality KPIs Ensure local repackaging of products is performed in accordance with specifications and required licenses. Review all packaging artworks from a local regulatory perspective as per internal / Corporate and local SOPs in place. Managing imported shipment, review of data loggers, and review all redressing artworks from a quality prospectives. Ensure proper system utilization for eDMS / PATH / Trackwise/Smartcockpit- participate as admin for mentioned software. To Support cross functional team in review and approval of GMP documents Execute assigned task by line manger on time-to-time basis.

Major Accountability Adherence to the current GxP and compliance requirements of Sandoz, perform and deliver Quality Operations in support of product quality compliance and regulatory workflows. Ensure compliance to the Sandoz quality standards, relevant regulatory requirements, filed product quality standards and service level agreements. Support implementing service quality and process improvement projects, CAPA management within GQSI. Comply with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processes. Regularly communicate with customers and partners to collect feedback on support services, report deliverables. Focus on timely completion of all relevant and assigned trainings. Learn & develop understanding to generate insights through data and digital. Ensure responsibility and ownership of the assigned tasks. Comply with accuracy and timeliness of deliverables. Hold accounts in workflow applications (such as SAP, GxQEM, CONDOR, ESOPs, TrackWise etc.) to ensure appropriate execution of service deliverables. Generate and analyse predefined and ad-hoc reports in various applications (like Trackwise, GxQEM, etc.) and perform follow-up actions, if required. Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! The future is ours to shape!

Seeking suitable candidates to support the administration and daily operations of the TrackWise Quality Management System (QMS). The role includes responsibilities such as Configuration, workflow management, reporting, and providing support for quality and compliance-related activities. Key Responsibilities: Handling of QMS events such as Deviations, RCI, CAPA, and Change Management associated with TrackWise. Configurations and Enhancements activities in the TrackWise application across all the modules. Support users with system navigation and basic troubleshooting. Assists in business process definition and TrackWise requirements gathering, training, etc. Participate in process simplification and automation. Assistance for user training and documentation related to TrackWise processes. Participate in validation activities and assist in creating documentation, functional testing throughout the project life cycle. Qualifications: Bachelor’s degree/ Master’s degree in IT, Life Sciences or any related field. Basic understanding of GMP, quality systems, or pharmaceutical industry processes. Hands on experience with TrackWise application or other QMS tools. Excellent communication and organizational abilities.

Project Role: IT Compliance Advisor Experience: 4-7 years Job Location: Bengaluru/Pune/Kochi Work Mode: Hybrid Must Have Skills: Compliance, Validation and Testing, GXP, System life cycle Domain Knowledge: Healthcare, CRO, Life Science Job Description Summary: Compliance and Validation Hands-on experience in compliance and validation roles Strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5 System validation aligned with regulatory standards Review of validation artifacts and identification of traceability or documentation gaps System Life Cycle and Methodologies Well-versed with System Life Cycle Hands-on experience with Validation approach, Agile methodology, AIML concepts Testing/Validation Experience Review and preparation of: Test Plans, Validation Plans, Risk Assessments Requirement Traceability Matrix (RTM), Summary Reports Understanding of the defect lifecycle and validation deliverables Tools and Technologies Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems Quality & Domain Expertise Knowledge of Quality Management Systems (QMS) Experience in Healthcare, CRO, or Life Sciences environments Good to Have Skills : Experience with SaaS validation, automation, and vendor audits Participation in internal/regulatory audits Strong documentation skills (SOPs, templates, work instructions) Familiarity with risk-based validation and data management Educational Qualification: Any Graduate

Job Title : Smart Connected Products - Manager-S&C GN Management Level: 07 - Manager Location: Bangalore/ Must have skills: Have Experience with leading MedTech solutions effectively by providing value-add to the processes, designs, methodologies, and business models Good to have skills: Have business Acumen to drive actionable outcomes for clients Possess analytical and outcome-driven approach Demonstrate a strategic Mindset to understand shape innovative, fact-based strategies and operating models Ability to communicate and present skills to share the perfect pitch with key stakeholders Have team building skills to collaborate, work and motivate teams with diverse skills and experience to achieve goals Job Summary: As part of the Smart Connected Product Design & Development (SCPDD) team you will create Connected Products based solutions in the MedTech space that provide vital digital intelligence and drive organizational changes for some of the world's best product companies. Roles & Responsibilities: Have business Acumen to drive actionable outcomes for clients Possess analytical and outcome-driven approach Demonstrate a strategic Mindset to understand shape innovative, fact-based strategies and operating models Ability to communicate and present skills to share the perfect pitch with key stakeholders Have team building skills to collaborate, work and motivate teams with diverse skills and experience to achieve goals Demonstrate leadership skills along with strong communication, problem solving, organizational and delegation skills Professional & Technical Skills: At least 10+ years in MedTech and Life Sciences across the value chain with experience to lead Strategic Projects with a global top Pharmaceutical, Medical Devices, Biotechnology or Healthcare Consulting firms Experience with QMS development and alignment from beginning to end of project cycle and be comfortable working with and according to the industry norms and existing processes. Comfortable with platforms including Trackwise, Veeva etc. Experience of developing commercialization strategy and launching medical devices in new markets End to End development of Personal Health Record (PHR) System as per HL7 PHR-S Functional Model Experience with integrating new technologies for EMR & PHR and medical devices Understanding of In-Hospital and remote fetal monitoring system, Remote ECG Monitoring system and Medical Device connectivity with EMR system Understanding of gateway connectivity with EHR, PACS and multiple devices such as C-Arm, Ultrasound, Laser, saline devices etc. Implementation of Healthcare Information System (HIS), Radiology Information System (RIS), Pharmacy Solution & e-Health solution at Healthcare Providers In-depth understanding of Medtech, Digital health, Cybersecurity, Connected Health Strategy (DTx and SaMD), Point of care diagnostics and Digital/Robotics Surgery Experience in business scoping, assessment and planning that includes Blueprinting, business case creation and business process redesign Experience in Project Management: Transform Product Strategies, Product Management, and overall engineering by enabling portfolio alignment with overall business strategy, right products mix with optimal resource utilization and better governance thereby ensuring increased product success Develop assets and methodologies, point-of-view, research or white papers for use by the team and larger community Lead proposals, business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with client’s business strategy and context for change. Engage stakeholders in the change journey and build commitment for change. Additional Information: Exceptionally organized Detail oriented Good judgement in how to engage with senior stakeholders regarding approvals/ follow ups Strong communication skills Proactive and able to work independently Sensitivity and skill at working with different cultures and styles A highly motivated self-starter About Our Company | Accenture , Experience: 10+ years of Industry Experience Educational Qualification: Engineering background with MBA preferred

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Responsible for effective review and approval of Laboratory investigation reports / Deviations / Corrective and preventive actions (CAPA’s)/ change controls/ method transfer/ validation protocols and reports in a timely and compliant manner. Job Responsibilities Review and approval of lab investigation reports , Deviations, Corrective action and preventive actions (CAPA’s) and Temporary change controls. Provide guidance on technical assessment/ investigations to team members and stake holders to ensure compliance. Review of standard operating procedures. Assessment and approval of change controls. Review and approval of instrument qualification and calibtration documents in timely manner. Review and approval of method transfer and validation protocols/ reports. Review and approval of specifications and MOA. Provide support to self inspections and audits by regulatory authorities / third parties as required. Responsible and accountable for managing subordinates and to provide all required training requirements, tools and follow procedures in accordance with applicable regulatory and other pertinent requirements. Provide training as required. Recruit, train, develop and manage effectively the ongoing performance of the direct reports, which includes but not limited to: Reviewing and updating team developing plans, ensuring that all the team members are properly trained and qualified to execute their duties. Providing coaching, feedback and recognition. Perform all work in support of our corporate values of collaboration,courage, perseverance and passion. Demonstrates strong and visible support of values. Communicate corporate vision and goals to direct reports in an effective and efficient manner. All other duties as assigned. Job Requirements Education Minimum Bachelor of Pharmacy / Science or any equivalent degree. Knowledge, Skills and Abilities Possess sound knowledge in quality management system which comprises of change controls, deviations and LIR’s Hands on experience in Trackwise application, LIMS and Empower application. Maintains good interpersonal skills and communication skills. Knowledge on method transfer and validation activities. Experience Minimum 8-12 years of experience in GMP regulated pharmaceutical industry. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Planning and executing various analytical method development, validation for new products, comprehensive testing of API and finished dosages with all established regulatory and compliance and safety requirements. Review of laboratory data, instrument logbook and reports wherever applicable. Initiation of departmental CCR's and tracking the progress to execute the proposed changes through QMS system. Preparation of TAP (Transfer of Analytical Procedures) protocol and Report for various sites. Procuring respective samples and Impurities accordingly. Planning and executing the assigned TAP projects to various sites. Preparation, maintenance and archival of regulatory submission documentation like SOP, protocols, reports for method development and validation. Job Responsibilities Prepares working plan for assigned projects and provides timeline to Manager. Develops stability indicative analytical methods for drug substance and finished product Responsible for all activities in Analytical Development, including cGLP, documentation and implementation of departmental quality systems. Applies AQbD approach to analytical method development where applicable. Responsible for protocol preparation, planning, execution, review and report preparation of various analytical method validation parameters. Ensures analytical methods validation is conducted according to approved validation protocols in a timely manner with accuracy and precision in compliance of laboratory SOP and guidelines. Responsible for method verifications and publishing of analytical methods. Maintenance and archival of analytical method validation documents. Performs all analytical tests for drug substance, including assay, related compounds, identifications and wet chemistry for API evaluation. Performs all analytical tests for PE/PO samples, including assay, degradation products and dissolution. Performs all analytical tests for API releasing, including assay, degradation products, dissolution and physical testing. Conducts other tests required for dosage submissions. Conducts lab investigations for OOS and OOT results. Raising Change control for various analytical activities (Method SOP and department SOPs) by QMS trackwise To prepare General, Operation and Calibration Standard Operating Procedures. Responsible for initiation, execution and completion of technology transfer and collaborative validation activities of analytical methods to and / or from other departments of Apotex wherever applicable. Responsible for technology transfer and Transfer of analytical procedures activity to support the supervisor. Communicating the requirements for the Leaders and within the team members for effective cGLP procedures and departmental quality systems to achieve all outcomes. With minimal guidance, performs troubleshooting on complex issues with respect to the stability of drug substances and drug products. To participate in the mandatory trainings to execute the day to day job responsibilities. Assist in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GLP. Develops and maintain strong relationships within Analytical R&D to ensure that the projects are delivered on time. Practice and up-gradation of knowledge with respect to cGMP. Performs all work in accordance with all established regulatory and compliance and safety requirements. Participates in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GMP requirements. Ensures all instruments assigned with responsibility within group/department are well maintained. Performs the calibration of instruments in Analytical R&D and ensures the compliance as per cGLP requirements. Work as a member of a team to achieve all outcomes. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education A graduate/post graduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field. Knowledge, Skills and Abilities knowledge of the instrumentation such as HPLC, GC, UV, IR spectrophotometer and dissolution apparatus, wet chemistry and analytical bench techniques. Knowledge in HPLC method development and method validation. Knowledge on preparation and review of various documents like SOP's, Formats, Protocols, Reports, analytical data, investigation and deviation reports. Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities Should possess troubleshooting knowledge on Instruments and analysis. Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems. Working knowledge of LIMS is an asset. Good written and verbal English communication skills. Experience BSc with 5 years or MSc with 4 years or PhD with 2 years’ experience in a pharmaceutical lab in an R&D environment. Chromatographic method development and validation. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com. Job Summary Planning and executing various analytical method development, validation for new products, comprehensive testing of API and finished dosages with all established regulatory and compliance and safety requirements. Review of laboratory data, instrument logbook and reports wherever applicable. Initiation of departmental CCR's and tracking the progress to execute the proposed changes through QMS system. Preparation of TAP (Transfer of Analytical Procedures) protocol and Report for various sites. Procuring respective samples and Impurities accordingly. Planning and executing the assigned TAP projects to various sites. Preparation, maintenance and archival of regulatory submission documentation like SOP, protocols, reports for method development and validation. Job Responsibilities Prepares working plan for assigned projects and provides timeline to Manager. Develops stability indicative analytical methods for drug substance and finished product Responsible for all activities in Analytical Development, including cGLP, documentation and implementation of departmental quality systems. Applies AQbD approach to analytical method development where applicable. Responsible for protocol preparation, planning, execution, review and report preparation of various analytical method validation parameters. Ensures analytical methods validation is conducted according to approved validation protocols in a timely manner with accuracy and precision in compliance of laboratory SOP and guidelines. Responsible for method verifications and publishing of analytical methods. Maintenance and archival of analytical method validation documents. Performs all analytical tests for drug substance, including assay, related compounds, identifications and wet chemistry for API evaluation. Performs all analytical tests for PE/PO samples, including assay, degradation products and dissolution. Performs all analytical tests for API releasing, including assay, degradation products, dissolution and physical testing. Conducts other tests required for dosage submissions. Conducts lab investigations for OOS and OOT results. Raising Change control for various analytical activities (Method SOP and department SOPs) by QMS trackwise To prepare General, Operation and Calibration Standard Operating Procedures. Responsible for initiation, execution and completion of technology transfer and collaborative validation activities of analytical methods to and / or from other departments of Apotex wherever applicable. Responsible for technology transfer and Transfer of analytical procedures activity to support the supervisor. Communicating the requirements for the Leaders and within the team members for effective cGLP procedures and departmental quality systems to achieve all outcomes. With minimal guidance, performs troubleshooting on complex issues with respect to the stability of drug substances and drug products. To participate in the mandatory trainings to execute the day to day job responsibilities. Assist in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GLP. Develops and maintain strong relationships within Analytical R&D to ensure that the projects are delivered on time. Practice and up-gradation of knowledge with respect to cGMP. Performs all work in accordance with all established regulatory and compliance and safety requirements. Participates in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GMP requirements. Ensures all instruments assigned with responsibility within group/department are well maintained. Performs the calibration of instruments in Analytical R&D and ensures the compliance as per cGLP requirements. Work as a member of a team to achieve all outcomes. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education A graduate/post graduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field. Knowledge, Skills and Abilities knowledge of the instrumentation such as HPLC, GC, UV, IR spectrophotometer and dissolution apparatus, wet chemistry and analytical bench techniques. Knowledge in HPLC method development and method validation. Knowledge on preparation and review of various documents like SOP's, Formats, Protocols, Reports, analytical data, investigation and deviation reports. Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities Should possess troubleshooting knowledge on Instruments and analysis. Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems. Working knowledge of LIMS is an asset. Good written and verbal English communication skills. Experience BSc with 5 years or MSc with 4 years or PhD with 2 years’ experience in a pharmaceutical lab in an R&D environment. Chromatographic method development and validation. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Job Title: QA Executive – Oral Solid Dosage (OSD) Location: Dabaspet , Bangalore - 562111 Department: Quality Assurance Industry: Pharmaceuticals Experience: 2–5 years (OSD QA experience mandatory) Employment Type: Full-time About the Company: We are a leading pharmaceutical manufacturer based out of Bangalore committed to delivering high-quality oral solid dosage formulations. Our facility is WHO GMP-compliant and serves both domestic and regulated international markets. We are currently looking for a dedicated QA Executive to strengthen our Quality Assurance team. Role Overview: The QA Executive will play a critical role in ensuring product quality and regulatory compliance across all stages of manufacturing. The candidate will be actively involved in quality systems, in-process controls, documentation review, and regulatory readiness. Key Responsibilities: Review and approval of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) Execution and review of process validation, cleaning validation, and hold time studies Line clearance, in-process checks, and compliance monitoring on the shop floor Handling deviations, CAPA, change controls, and quality risk management Coordination for internal audits, regulatory inspections, and customer audits Oversight of document control and SOP implementation Ensuring adherence to cGMP, GDP, and data integrity practices Supporting cross-functional teams including production, QC, and RA Required Qualifications & Skills: B.Pharm / M.Pharm / M.Sc (Chemistry or related discipline) 2 to 5 years of relevant experience in QA within an pharmaceutical manufacturing setup Sound understanding of regulatory guidelines (USFDA, EU-GMP, WHO-GMP, etc.) Strong documentation and communication skills Proficient in handling QMS activities and audit preparedness Familiarity with electronic systems like TrackWise, LIMS is an advantage

Date: 14 Jul 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Essential Functions Job Title: Digitization Lead. Job Location: Syngene International Limited, Bengaluru About Syngene: Syngene (www.syngeneintl.com) 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. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit. Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene’ s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose Of The Role To act as System SME and ensure compliance activities related to ERP systems ensuring adherence to regulatory requirements and internal policies, thereby supporting quality assurance and data integrity in Syngene’s operational systems. Role Accountabilities Prepare, review, and approve validation deliverables including Impact Assessments, User Requirements Specifications (URS), Functional Requirements Specifications (FRS), and Validation Reports compliant with 21 CFR Part 11, EU Annex 11, and GAMP5 Implementation of ERP systems (Ex SAP, EDMS, Track Wise….) and maintain the system in validated state. Plan and execute installation, operational, and performance qualification (IQ, OQ, PQ) testing to verify system functionality and compliance Collaborate with IT, QA, and business stakeholders during system testing, deployments, and upgrades for ERP systems such as EQMS, Documentum, SAP Assess and manage risks and impacts associated with ERP system changes and new implementations Ensure adherence to company SOPs, regulatory guidelines, and quality standards throughout validation lifecycle Act as subject matter expert during internal and external audits related to ERP system validation and compliance Identify compliance risks proactively and implement corrective/preventive actions Mentor and guide junior team members on validation compliance best practices Manage investigation and closure of deviations and issues arising from validation and audit activities Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience: Experience in validation and compliance of GxP regulated ERP systems including EDMS (Documentum-LSQM), EQMS Trackwise, and other ERP platforms 13-18 Years of domain experience. Demonstrated ability to support audits and manage compliance risks effectively Demonstrated Capability Detail-oriented with strong analytical and problem-solving skills Ability to manage multiple priorities, meet deadlines, and to meet quality norms Skills And Capabilities Experience in preparing and reviewing validation documentation and conducting ERP system qualification testing Strong working knowledge of data integrity, good documentation practices, and regulatory requirements such as 21 CFR Part 11, EU Annex 11, and GAMP5. Excellent communication and stakeholder management skills to work effectively across IT, QA, and business functions Ability to mentor and train junior team members Education Master’s degree in Science, Pharmacy, Biotechnology, B. Tech, or IT-related field Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, 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.

Date: 14 Jul 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Essential Functions Job Description Job Title : Manager Development Quality Assurance (BRDS) Department : Discovery and Development QA Job Location: Bengaluru, India About Syngene: Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA. Key Result Areas We are seeking an experienced and dynamic Quality Assurance lead to manage research and development quality assurance division at Bicara Research and Development at Syngene (BRDS). This role will involve implementing Syngene Quality Assurance principles for Biologics development and ensuring compliance to quality systems throughout the life cycle of R&D projects. Mandatory expectation Responsible and accountable towards safety and compliance in all the work activities in the own responsibility area(s). Monitor and confirm that the established Environment, Occupational Health, Safety and Sustainability (EHSS) practices for safe work environment are followed by self and direct reports. Monitor and confirm that self and direct reports adhere to the highest standards of quality, integrity and compliance for every work activity. Complete the assigned training in a timely manner and comply with the training procedure and training calendar and monitor and confirm the same for the direct reports. Attend all assigned mandatory training related to data integrity, health and safety measures, and monitor and confirm the same for the direct reports. Participate and support the training on procedures, protocols and On-the-Job activities. Comply with Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP). Report nonconformities and deviations to the respective supervisor(s) and/or line manager(s). Participate and support on-time initiation and closure of deviations, investigations, CAPA and change controls. Educational Qualification Masters or Doctorate degree in Pharmaceuticals, Biotechnology, Engineering or any stream of Science. Profile Description This role will be responsible for crafting the allocation methodologies and process flows for Development services. This individual will collaborate actively with Operation units of development services for Bicara to improve alignment and achievement of customer satisfaction and value realization Core Purpose Of The Role Responsible for Quality Systems of Development Services and relevant QA activities. Role Accountabilities Lead Quality Management System activities pertaining to Bicara Research and Development at Syngene. Liaise with Bicara Global Quality to align on quality principles and process flow for discovery and development projects at BRDS. Execute quality risk assessment across different development stages of Biologics Discovery and Development and implement phase appropriate QMS principles. Ensure that OOS, Deviations, Customer Complaints are investigated, reviewed and CAPA implemented in accordance with QMS requirements. Ensure change controls are assessed. Coordinating with Cross functional team other GxP functions for the implementation of Quality Management System (QMS). Training of employees on QMS procedures. Prepare / Review of documentation such as Quality Manual, Site Master Files, SOPs and Quality Agreements. Planning and follow-up of QMS activities for closure within the target timeline for Biologics Operation Units. Preparation of QMS Metrics within BRDS. Preparation and review of risk assessment for Quality activities. Preparation and review of trends as per schedule for all QMS elements as applicable. Liaise with and support the Internal Audit and Continuous Improvement team for the timely closure of the CAPA. Facilitate continuous improvement via QMS to improve the health of the Quality Systems. Participate and coordinate the client and regulatory audits for Biologics Discovery and Development Labs. Development of team skills within Biologic-QA team, motivating, coaching and mentoring direct reports to higher levels of management capabilities. Review of SOPs within QA, periodic review of the SOPs implemented across the functions. Ensure quality compliance against regulatory requirements and revise SOPs as necessary to comply with these regulations. Accountable for reviewing and approving protocols, SOPs, IOPs and documents related development, method qualification, Specifications, Tech-Transfer, etc. Responsible for approval and timely availability of Technology Transfer from Development services to Manufacturing services; Analytical Method and Process Development Transfer documents. Develop role-based training modules for BRDS and ensure training of staff on quality procedures, processes, policies and issue training binders. Implement phase appropriate quality procedures and DI related training across operating units. Review and approval of Quality Assurance procedures in EDMS and TrackWise. Implementation of role-based curricula in Discovery and Development Services and ensure compliance. Approve annual training planner, instrument audit trail and eLN audit trail schedules. Contributing to development procedures, practices, and systems that ensure safe operations and compliance with the company’s integrity and quality standards. Coordination with cross-functional teams to complete the assigned work on time such as data review, report approval, etc. Execute root cause investigation by performing why-why analysis and propose mitigation strategies and implement CAPAs. Responsible for facing audits by clients and regulatory bodies. Lead regular meetings with team members to communicate operational information and objectives. Evaluate team performance periodically and identify areas in need of improvement to implement development strategies. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Experience 10+ years of experience in driving quality assurance in pharmaceutical/biopharmaceutical industry Skills And Capabilities Proven track record in implementing QMS in biologics development and QC labs. Strong understanding of biologics development process flow including early-stage process development, scale-up and technology transfer. Good knowledge of international quality guidelines applied for biologics drug development including ICHQ, USP, etc. Knowledge of electronic notebooks and should be well versed in TrackWise QMS Software for raising Deviation, Change Control and CAPA. Excellent interpersonal communications with track record of working in dynamic environment

Trackwise Consultant Experience: 5 to 8 Years Location:- Bangalore/Pune/hyderabad Notice period : Immediate to 15days Job Description Knowledge of Trackwise is a must Should have indepth knowledge of handling Quality management in TrackWise Should have a strong understanding of Trackwise Business processes such as Change Management System IncidentDeviation Investigation CAPA implementation etc Should have a deep understanding of the individual workflowsapprovals in each Trackwise Module Experienced in generating various types of queries in TrackWise requirements Well versed knowledge of Quality Risk assessment through TrackWise Application Should have managed QMS implementation projects including configuration migrations data migration multisite rollouts data archival etc Should have adequate knowledge in performing gap assessments from an end user perspective Need to ensure quality assurance procedures are followed and in accordance with Customers methodology and standards Minimum 5 years of experience in a Pharmaceutical Life Sciences setting is preferred Experience with industry standard and best practices regarding quality quality assurance and quality control principles and techniques eg 21 CFR Part 11 GAMP 5 Versed in health authority regulations such as FDA 21 CFR MHRA Annex 11 Subject Matter Expert in GxP GDP GLP GMP and Data Integrity Mandatory Skills : Architecture Principle Design, Software Engineering and Design Architecture, Trackwise

Job Description Major Accountability: Adherence to the current GxP and compliance requirements of Sandoz, perform and deliver Quality Operations in support of product quality compliance and regulatory workflows. Ensure compliance to the Sandoz quality standards, relevant regulatory requirements, filed product quality standards and service level agreements. Support implementing service quality and process improvement projects, CAPA management within GQSI. Comply with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processes. Regularly communicate with customers and partners to collect feedback on support services, report deliverables. Focus on timely completion of all relevant and assigned trainings. Learn & develop understanding to generate insights through data and digital. Ensure responsibility and ownership of the assigned tasks. Comply with accuracy and timeliness of deliverables. Hold accounts in workflow applications (such as SAP, GxQEM, CONDOR, ESOPs, TrackWise etc.) to ensure appropriate execution of service deliverables. Generate and analyse predefined and ad-hoc reports in various applications (like Trackwise, GxQEM, etc.) and perform follow-up actions, if required. Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! The future is ours to shape!

Job Title Senior Manager - Production Business Unit Sun Global Operations Function Production (OSD) Location : Mohali Key Responsibilities At Sun Pharma, we commit to helping you “ Create your own sunshine ”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Position Summary – Planning of Production and Packing activities as per requirement to achieve the monthly targets To review the Production activities on daily basis for Granulation, Compression, Coating, Capsule filling, Inspection, Packing and Nutra section as per daily production plan (Plan Vs Actual) To ensure Good Documentation Practices (GDP) at shop floor and packing area. To coordinate with IPQA/QC/Engineering/PPC/SCM/EHS & FDD/MSTG department for smooth functioning of Production and Packing activities. Handling of SAP related work in Production. To ensure online documentation as per cGMP practice in Production area. Implementation of best practices on shop floor with respect to cGMP and to ensure that all activities of production and packing area are carried out in compliance with cGMP and safety guidelines. To review SOPs, user requirement specification (URS), purchase requisition (PR), Investigations, Process validation protocol/report, Equipment qualification protocol/report and other QMS documents. To handle the QMS activities in Trackwise /EDMS to review/approve the documents. To ensure timely and smooth execution of commercial validation batches. To ensure proper man power allocation and utilization in the Production/ Packing department. To impart and ensure on time training to officers and workers on cGMP, SOPs, GDP and EHS. To fill the daily assessment sheet as per the target assigned by the seniors. To involve in commercial product troubleshooting along with other departments to ensure timely delivery of product to market. To review technical protocols, reports related to investigational/ verification batches of approved products. To ensure that the products are produced and stored according to the appropriate documentation. To ensure on time implementation of corrective and preventive action (CAPA) with respect to investigation or audit findings or as and when required for compliance. To check the maintenance of the department, premises and equipment. Ensure timely review and implementation of master documents required for smooth production. To ensure timely preparation and review prerequisite documents required for execution of validation batches like BOMs, BMRs, protocols and reports etc. To ensure optimum capacity utilization, efficiency setting and productivity enhancement. Drives business excellence initiatives in production and packing area like Kaizen, Six sigma, 5S etc. To improve the production and packing process for less time, utility consumption and better quality. To report any deviation and abnormality of any type to seniors. To perform any other works as and when assigned by operation Head/Management. Travel Estimate Low Job Scope Internal Interactions (within the organization) Plant production teams and quality teams External Interactions (outside the organization) Limited with Vendors Geographical Scope Domestic Job Requirements Educational Qualification B.Pharm / M.Pharm Skills Behavioral skills: Attention to detail Initiative Learning Agility Compliance Functional Skills Knowledge of GxP’s, GMP and other regulatory requirements Experience 18 to 20 Yrs with OSD Production experience in regulated plants Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together! Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Manager 1 – Production Scheduling Location: Paonta Sahib Education: B. Pharma/M. Pharma/ MSc Experience: 12+ years in Formulation To ensure Formulation & Process Orders along with Batch Production Records for all Blocks in Plant are issued as per schedule by ensuring Good documentation practices. To co-ordinate effectively with all stakeholders i.e. PDL, RA, QC for availability of Recipes, LP's, RM & PM Releases to meet production plan. To ensure allocation of batches in respective SKU's as per commits. To ensure smooth functioning of Production by ensuring RM/PM Recipe/LP I s are available timey to run Packing Lines as per Schedule. To ensure allocation & packing of critical & NIL supply SKU's To maintain System Hygiene by timely closure of unwanted Process Orders so as to avoid hampering of MRP run. To attend S&OP meetings & respond to market queries. To provide additional testing request as per desired market specification. To provide Code to code request to meet market requirement based on approval from all stake holders. To ensure Inventory Reduction and Control To keep track of Non Moving & Rejected items. To provide Batch specific details for procurement of Batch Specific Foil To ensure WIP control and RM/& PM short expiry materials, nearing expiry are consumed to Avoid consumption of fresh items, Retest times are given priorities for releases. To raise Locking & Unlocking forms request as per INTM Linkage request details provided by Production QMS. To complete task assigned in TrackWise and time to time Revision of SOP007691 Procedure of Batch Production Record

Role & Responsibility To meet the production schedule both in quality and quantity. To maintain good discipline in the Packaging area and department. To ensure the implementation of EHS practices during the work To plan the activities of the area as per daily basis schedule To plan & allocate different jobs on daily basis to workmen/ machine operators of Secondary and primary Packing area. To check and verify the transfer of Primary Packing Material from P.M. staging to process area To ensure implementation of Good Packaging Practices and SOP during work. To maintain and improve quality of the products as per standard’s. To ensure the effective control on usage of men, machine and material in the department. To participate and co-ordinate various ongoing validation activities of equipment and system. To organize and implement the on-job training activities in the department. To supervise the Primary and Secondary Packing activities To ensure training completion of all employees working in secondary and primary area activities.. To conduct investigation of OOS, monitor CAPA and handle deviations. To ensure instruction of validation protocols, change controls, deviations, SOPs and specifications relating to production and ensure their strict implementations.. To maintain department and equipment in neat and tidy condition all the time. To control the rejection during secondary and primary packaging operations. To do counseling and grievance handling of the subordinates. To review the Batch Production Records after completion of the BPR. To perform any other related work allotted by the superior as per the production requirement. To work for the control of wastages during Packaging and to achieve higher yields of product. To perform all the trackwise and SAP related work. Any other responsibility to be completed that may be assigned for time to time. To perform investigation for Market Complaint and Deviations & handling of change controls. Completion of all the record work on daily basis

Position Executive Job Title Executive Job Grade Function: Corporate Quality Compliance Sub-function Complaints Manager’s Job Title Senior Manager-1 Skip Level Manager’s Title Function Head Title: Head of Global Quality Systems Complaints Location: Vadodara No. of Direct Reports (if any) Nil Job Summary Logging of Product Quality Complaints (PQC) in the database (TrackWise). Acknowledge the complaints to the complainants. Providing the response letter to the complainant. Reconciliation of received market complaints. Review of Product Quality Complaint Investigation Reports (India Market). Coordinate with other stakeholders involved in the complaint handling process. Areas of Responsibility Product Quality Complaints Management Travel Estimate Approximately 5% Job Scope Internal Interactions (within the organization) Yes External Interactions (outside the organization) Nil Geographical Scope India Financial Accountability (cost/revenue with exclusive authority) Nil Job Requirements Educational Qualification M.Sc (Life Sciences) / B.Pharm Specific Certification Nil Skills Good Technical & Communication Skills, minimum 1 year experience in complaints handling process, candidate should have worked in USFDA work environment. Experience 4-6 years Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Position Executive Job Title Executive - CQC Job Grade G12A Function Corporate Quality Compliance Sub-function Product Quality Complaints Manager’s Job Title Senior Manager-1 Skip Level Manager’s Title Head of Global Quality Systems Complaints Function Head Title Linda Savage Location: R & D Tandalja, Vadodara No. of Direct Reports (if any) Nil Job Summary Logging of Product Quality Complaints (PQC) in the database (TrackWise). Acknowledge the complaints to the complainants. Follow up with the complainant for complaint sample and additional information to support Product Quality investigation. Providing the response letter to the complainant. Coordinate with other stakeholders involved in the complaint handling process. Reconciliation of received market complaints. Areas of Responsibility Product Quality Complaints log in management. Travel Estimate Less than 5% Job Scope Internal Interactions (within the organization) Yes External Interactions (outside the organization) Yes Geographical Scope India Financial Accountability (cost/revenue with exclusive authority) Nil Job Requirements Educational Qualification M.Sc / B.Pharm Specific Certification Nil. Skills Hands on experience in computer handling. Good Knowledge in MS Office. Fluency in English. Experience 0 to 3 years Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Position: Sr. Manager 2 - CMO Department: Global Quality CMO Location : Mumbai/ Baroda Reporting Manager Title : DGM- CMO Job Summary To ensure that SUN Pharma Quality and Compliance Standards, and applicable global regulatory authorities’ requirements are met and that all SUN affiliates, CMO, Suppliers and SUN sites / Operational Units to achieve, maintain and improve the adequate level of compliance, through “Quality Oversight” and “Independent auditing and Follow-up”. Essential Job Functions Participate in the initial evaluation of Contract Manufacturing Organizations (CMOs). Oversee and approve Quality Management System (QMS) elements reported by CMOs, including change control, deviations, incidents, Out of Specification (OOS)/Out of Trend (OOT) results, and complaint investigations. Review and approve master documents from CMOs, such as Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), specifications, validation protocols, and stability protocols. Provide support during regulatory audits at CMO sites related to SUN Pharma product approvals. Engage in critical investigations at CMO sites, including OOS results, deviations, and complaints. Review and maintain quality agreements with CMOs to ensure compliance and quality standards. Initiate QMS documents in the Trackwise system, inform the respective CMO, and track to ensure closure of initiated QMS elements. Monitor and oversee activities carried out at CMO sites to ensure compliance with SUN Pharma standards. Review executed documents from CMOs related to SUN Product to ensure accuracy and compliance. Perform batch release of SUN products manufactured at CMO sites, ensuring they meet quality standards. Conduct regular visits to CMO sites, prepare detailed visit reports, and follow up on any issues identified. To makes sure that, SUN Manufacturing Sites, Contract Manufacturing Organisations, and Affiliate Companies are prepared for Regulatory Agency Inspections e.g. through "Mock" inspections, audits and supports activities whenever required . To participate in the product release sites / Qualified Person sites audits to ensure that the product is being released as per the regulatory requirement. To prepare Monthly report and to highlight the key area of concerns. To participate in the trainings to update on current / upcoming regulations. To follow the Corporate Quality Policies/ Global Quality Standards (GQS) and applicable Regulatory Guidelines. Participate and execute the project work as allotted by reporting authority. To perform the risk assessment. Requirements And Qualifications M.Sc./ B. Pharm / M. Pharm or equivalent. Industrial Experience & Knowledge Total 15-18 years of experience Experience in CMO and working knowledge with Regulatory markets is preferable.

Role & responsibilities 1) To perform the analysis by following cGMP, GLP, ALCO+, and safety compliance 2) To perform the sampling, testing of RM, PM, In-process, Intermediate and Finished product. 3) Participate in Investigation of deviation, Incident, OOS etc. 4) To perform all qualification activities of instrument and equipment in QC Lab. 5) Aware of calibration and operation procedure for instruments ( balance, K.F, GC. UV,refratometer and viscometer etc,) 6) Experience of QC software like Tiamo 3.0, Lab solution, SCM etc. 7) Preparation of documents ( SOP, protocol etc) related to Quality control. Kindly Send CV to mail ID, jagpal.dewal@ipca.com vishal.rankham@ipca.com

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Manager Date: Jul 14, 2025 Location: Ahmednagar - Engineering Company: Sun Pharmaceutical Industries Ltd 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. Apply Now » Apply Now Start applying with LinkedIn Please wait...