169 Oq Jobs

Day-to-day design and documentation activities (i.e. Validation Documents, DQ, IQ, OQ, Operating Instruction Manual etc. AutoCAD 2D Drawing (GA Drawing, Layouts, Part Drawing) Measuring Instruments & Basic Knowledge of Standard Mechanical Components.

Quality Assurance Compliance Specialist Location: Pune-Hybrid working-Twice a week in the office Status: Permanent, Full Time Package: Competitive Salary (fixed), 5 Day Working Week, Flexible Working (with one-off allowance), Development & Opportunity (Personal & Technical), Group Medical Policy, Group OPD Cover, Personal Accident Cover, Term Life Cover, 26 Days Leave + 9 Public Holidays + Buy & Sell Scheme, Referral Scheme. Why are we hiring a Quality Assurance Compliance Specialist? Were on the hunt for a Quality Assurance Compliance Specialist as part of our company’s growth. The Quality Assurance Compliance Specialist provides day-to-day support for Quality Assurance and Information Security Management teams and other activities as required within the Governance, Risk Management and Compliance group (GRC), to help ensure our quality and information security objectives are met at all sites and to allow the business to reliably manage governance, identify and manage risks and provide independent oversight to ensure the business remains compliant accordingly. Who’s Instem? Well, we’re a global provider of bespoke industry-leading software solutions and services, which facilitate the pre-clinical, and clinical phases of the drug discovery process. We have over fifteen products in our portfolio, used by over 700 pharmaceutical clients (including all the top 20!) Instem is a unique, solutions-based organisation. Our 5-year growth plan is progressive, and we need you to help us reach that next level! What’s the culture/environment like? For a global business of over 300 staff, we very much have a family feel. You’ll be part of a friendly, communal, solution based, flexible environment, where you’ll feel empowered, valued and accountable. We’ll invest in you as a person and encourage you to take part in companywide workshops for wellbeing, mental health, critical conversations, and strengths. What are you responsible for? Planning and executing Internal Process Audits Execute Software Release Audits Supplier Assessment/Qualification/Performance Reviews (quality aspects) Review, authoring and modifying and preparing for publication management system documents Logging/tracking corrective action updates Adherence to the Company’s Quality and Information Security Management Systems to ensure that all work is handled Securely, Professionally and Diligently To be successful in this role, you will need: Certified lead auditor for ISO 9001 Skilled at building good working relations with auditees and their managers Sound planning and coordination skills Broad knowledge of Instems products and services Broad technical understanding of software development lifecycle Knowledge of Quality Management and Information Security Management and its application to tasks associated with this role Conversant with GxP such as 21 CFR Part 58 and ERES such as 21 CFR Part 11 Daily, millions of lives are improved by the Instem technologies and services that have been deployed by our clients. This is a fantastic opportunity for you to help save and prolong people’s lives, by doing what you do best! An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Instem stores and processes data using an Applicant Tracking System (ATS). For more information regarding our privacy policy use the following link: https://www.instem.com/privacy/ #LI-PD #LI-Hybrid

As an experienced professional with 3-4 years of overall experience, you will be responsible for a variety of tasks in the manufacturing industry in Pune. Your role will involve the following key responsibilities: - Good in documentation, particularly in regulated industries like Medical device, Pharma, and Aerospace. Your experience in authoring documents and working with GDP will be highly beneficial. - Proficiency in statistics to support various activities within the manufacturing process. - Effective communication skills to facilitate discussions, especially in handling manufacturing activities. - Hands-on mentality to perform activities related to PV, such as TMV, IQ, OQ, and PQ. Experience on the shop floor would be advantageous. - Conducting gap assessments and remediation of documents with stakeholder inputs. - Understanding manufacturing-specific QMS documents for Class I, II, and III medical devices. - Supporting the development and introduction of new products, processes, and technologies with a focus on quality systems. - Managing development, regulatory compliance, and process risk management including pFMEA. - Creating and modifying process flows within Manufacturing/Service Departments. - Developing and maintaining Manufacturing/Service Work Instructions and related documents. - Creating and modifying fixtures, tooling, equipment, and systems to support operations. - Conducting IQ, OQ, and PQ of fixtures, tooling, and equipment. - Monitoring and driving corrective action, CAPA, and continuous improvement activities by conducting primary investigations, data analysis, and implementing corrective actions. - Supporting corrective and preventive actions in manufacturing using formal problem-solving tools and documentation. - Preference will be given to candidates with Medical Device Experience and knowledge of FDA 510 K, IS013485, and ISO 14971 standards. Your educational background should include a BE/B.Tech/ME/M.Tech degree. Make sure to bring your hands-on experience and expertise in documentation, communication, and quality systems to contribute effectively to the manufacturing processes and operations.,

Work Flexibility: Hybrid What you will do: Support the implementation of process improvements to Corporate/Site/Division Supplier Initiated Change Request procedures and process. Served as owner, execute, and maintain the electronic systems related to SICRs, and support data alignment (SICR Database & OnePLM SICR Library) Challenge suppliers SICRs forms for completeness and accuracy. Discuss corrections to the form to guarantee a smooth assignment and execution of the change. Own & Execute Supplier Initiated change request (SICR) submitted by Global Suppliers Review Submitted SICRs and challenge suppliers for missing information & required deliverables for approving the change Organize SCRB with Key Stakeholders and get Buy in for Type of change. Review and Approve deliverables submitted by suppliers and coordinate with supplier for any corrections. Execute ECR/ECNs and Promotion requests in OnePLM for Change Approval at Stryker end. Support communication tools to internal and external customers (suppliers/site/division) Monitor and Maintain SICR KPIs. Support Global SICR Initiatives What you will need: Required qualification: Honors Bachelors degree in Engineering or Science fields or equivalency. 3+ years of experience in manufacturing environment or equivalent. Basic knowledge with GMP, ISO 13485, 21 CFR Part 820 standards Good communication skills. Willing to travel in support of business needs to different geographical locations. Good knowledge of continuous improvement methodologies Hands on experience of PPAP ,MSA, SPC documentation creation, review and Approval from suppliers. Good Hands on experience of Validation activity IQ,OQ & PQ Good Know how of Manufacturing processes like welding, Molding, Machining etc. Good Hands on experience of PFMEA & Control Plan Preferred qualification: Must enjoy working in a team environment Must demonstrate good collaboration and communication skills. Highly motivated and able to build relationships internally and externally. Must demonstrate multitasking skills as this individual will be responsible for multiple tasks at the same time. The individual should enjoy working in a dynamic and results-oriented team environment focusing on quality, compliance and customer satisfaction Travel Percentage: 10%

Capgemini Invent Capgemini Invent is the digital innovation, consulting and transformation brand of the Capgemini Group, a global business line that combines market leading expertise in strategy, technology, data science and creative design, to help CxOs envision and build whats next for their businesses. Your Role Use Design thinking and a consultative approach to conceive cutting edge technology solutions for business problems, mining core Insights as a service model Engage with project activities across the Information lifecycle. Understanding client requirements, develop data analytics strategy and solution that meets client requirements Apply knowledge and explain the benefits to organizations adopting strategies relating to NextGen/ New age Data Capabilities Be proficient in evaluating new technologies and identifying practical business cases to develop enhanced business value and increase operating efficiency Architect large scale AI/ML products/systems impacting large scale clients across industry Own end to end solutioning and delivery of data analytics/transformation programs Mentor and inspire a team of data scientists and engineers solving AI/ML problems through R&D while pushing the state-of-the-art solution Liaise with colleagues and business leaders across Domestic & Global Regions to deliver impactful analytics projects and drive innovation at scale Assist sales team in reviewing RFPs, Tender documents, and customer requirements Developing high-quality and impactful demonstrations, proof of concept pitches, solution documents, presentations, and other pre-sales assets Have in-depth business knowledge across a breath of functional areas across sectors such as CPRD/FS/MALS/Utilities/TMT Your Profile B.E. / B.Tech. + MBA (Systems / Data / Data Science/ Analytics / Finance) with a good academic background Minimum 10 years + on Job experience in data analytics with at least 7 years ofCPRD, FS, MALS, Utilities, TMT or other relevant domain experience required Specialization in data science, data engineering or advance analytics filed is strongly recommended Excellent understanding and hand-on experience of data-science and machine learning techniques & algorithms for supervised & unsupervised problems, NLP and computer vision Good, applied statistics skills, such as distributions, statistical inference & testing, etc. Excellent understanding and hand-on experience on building Deep-learning models for text & image analytics (such as ANNs, CNNs, LSTM, Transfer Learning, Encoder and decoder, etc). Proficient in coding in common data science language & tools such as R, Python, Go, SAS, Matlab etc. At least 7 years experience deploying digital and data science solutions on large scale project is required At least 7 years experience leading / managing a data Science team is required Exposure or knowledge in cloud (AWS/GCP/Azure) and big data technologies such as Hadoop, Hive, What you will love about working here We recognize the significance of flexible work arrangements to provide support. Be it remote work, or flexible work hours, you will get an environment to maintain healthy work life balance. At the heart of our mission is your career growth. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities. Equip yourself with valuable certifications in the latest technologies such as Generative AI. About Capgemini Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of 22.5 billion.

Preparation of documents such as IQ, OQ, DQ Job Description- (Incumbent needs to do/ Needs to know/ Outcome anticipated) Preparation of Project documents such as IQ, OQ, DQ as per requirement Incumbent needs to know - Basics of documents such as IQ, OQ, DQ - Excel, Word Experience Handling documentation activities for Minimum 6 months, preferably for WT projects in pharma.

Job Overview As an R&D/Product Development Engineer, you will be responsible for implementing and growing the capabilities and services of balloons provided by the Components group, primarily with Balloons (extrusion and forming). This will be a fast-paced role where we design new products for new and existing markets, qualify tooling, and specify new capital equipment investments. You will also work alongside with Operations and parallel R&D teams to understand design criteria to optimize quality and maximize throughout. Responsibilities & Required Skills Responsibilities: Implement and grow new technology of Balloons (extrusion and forming) Procure & qualify capital equipment, tooling, and fixtures for development and manufacturing Subject matter expert in the material properties of thermoplastic polymers and balloon forming processes to ensure optimized design inputs and outputs Support development of equipment, process, and measurement strategy as related to Balloons Plans, organizes, and manages related projects and staff as appropriate Train, mentor, and provide direction to Operators and Technicians. Support sustainable operations as a subject matter expert Design and integrate related test methods Understand customers applications and design products to meet application demands Lead the development of balloon forming equipment, process, and measurement strategy Directly review and validate the measurement results of development balloon runs Collaborate across operations and engineering teams to build consensus, summarize data to drive progress, to draws conclusions, and to create recommendations Qualifications Bachelor s Degree in Chemical, Mechanical, Material Science, or other related fields. A minimum of 5 years of industry experience in a manufacturing environment Extrusion/Injection molding/related experience preferred Innovative idea-generator who enjoys leading teams and mentoring others Problem-solving mindset backed up by solid statistical analysis skills Self-starter, self-motivator with the ability to work effectively in a team environment 1+ years of experience of indirectly providing direction to support technicians is preferred IQ/OQ/PQ experience a plus Six Sigma, lean certification a plus SAP experience a plus Competencies Location

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Overview TE Connectivity's Manufacturing and Process Development Engineering Teams significantly impact LEANPD driven new product development projects, driving for excellence in existing manufacturing technologies and methods and striving to implement new manufacturing technologies to provide improved process and tolerance control. They act as the binding element between product development and manufacturing engineering, ensuring the effectiveness and efficiency of this critical interface. They support Product Development in the optimization of designs and piece parts for manufacturability by realizing sample tooling/products/prototypes. They also design, develop, and qualify tooling and processes to meet TE quality and production standards, document all processes and tooling in applicable TE systems, support supply chain to verify supplier compliance and capability, initiate and implement programs to continuously improve quality, cost and cycle time and adhere to all appropriate specifications, regulatory requirements and customer requirements. Responsibilities Complete prototype building and product testing in association with R&D Engineers. Complete process development to support new product development and implement manufacturing lines with the project teams. Conceptualize, source debug, and introduce new/improved Jig and Fixture designs. Preparation of Manufacturing Procedures & training of product builder personnel. Prepare and maintain Preventative Maintenance Schedules. Troubleshoot and repair line defective equipment. Ownership of line yield and output. Provide weekly updates and highlight yield issues and implement fixes to the team. Provide technical leadership and have the ability to motivate and influence production personnel. Display customer focus at all times and be accountable for quality and timeliness of own work. Compile IQ / OQ protocols and execution of same. Assist team in performing design testing. Fixture Maintenance /Calibration ownership for respective equipment. Basic understanding of QMS system. What your background should look like: Diploma in Mechanical /Production 2+ years experience in a similar role. Knowledge of Medical Device development/manufacture with previous work experience in Design an advantage. Jigs & Fixtures design and fabrication experience preferable. Experienced with all the popular software applications for generating office documents, spreadsheets, project plans, etc. Experience in execution of lab testing an advantagee.g. tensile testing, torque testing etc. Experienced in IQ/OQ/PPQ documentation preparation, execution. AutoCAD/Solid works experience preferable. Knowledge of Six-Sigma and Lean Engineering principles an advantage. Knowledge of equipment, process and product validation processes, ability with statistical data analysis. Dynamic, flexible approach to work with a results-oriented attitude. Comfortable operating within a team environment. Motivated to work on own initiative. Good communication and organisational skills. Proven track record of excellent timekeeping & attendance is essential. Basic Understanding of QMS Competencies

Job Overview As an R&D/Product Development Engineer, you will be responsible for implementing and growing the capabilities and services of balloons provided by the Components group, primarily with Balloons (extrusion and forming). This will be a fast-paced role where we design new products for new and existing markets, qualify tooling, and specify new capital equipment investments. You will also work alongside with Operations and parallel R&D teams to understand design criteria to optimize quality and maximize throughout. Responsibilities & Required Skills Responsibilities: Implement and grow new technology of Balloons (extrusion and forming) Procure & qualify capital equipment, tooling, and fixtures for development and manufacturing Subject matter expert in the material properties of thermoplastic polymers and balloon forming processes to ensure optimized design inputs and outputs Support development of equipment, process, and measurement strategy as related to Balloons Plans, organizes, and manages related projects and staff as appropriate Train, mentor, and provide direction to Operators and Technicians. Support sustainable operations as a subject matter expert Design and integrate related test methods Understand customers applications and design products to meet application demands Lead the development of balloon forming equipment, process, and measurement strategy Directly review and validate the measurement results of development balloon runs Collaborate across operations and engineering teams to build consensus, summarize data to drive progress, to draws conclusions, and to create recommendations Qualifications Bachelor s Degree in Chemical, Mechanical, Material Science, or other related fields. A minimum of 5 years of industry experience in a manufacturing environment Extrusion/Injection molding/related experience preferred Innovative idea-generator who enjoys leading teams and mentoring others Problem-solving mindset backed up by solid statistical analysis skills Self-starter, self-motivator with the ability to work effectively in a team environment 1+ years of experience of indirectly providing direction to support technicians is preferred IQ/OQ/PQ experience a plus Six Sigma, lean certification a plus SAP experience a plus Competencies Location

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. Job Description Roles and Responsibilities Establish and execute project quality plan, witness-points, quality records for compliance with contract. Ensure customer quality requirement, Feedback of Experience (FOE)/Lessons Learned are taken into account to avoid deviation and to continually improve execution processes. Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional strategy. A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations. Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance. Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions. Required Qualifications For roles outside of the USA- This role requires advanced experience in the Quality & QA Engineering. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience). For roles in USA - Bachelor's degree from an accredited university or college (or a high school diploma GED with at least 6 years of experience in Job Family Group(s)/Function(s)). Desired Characteristics Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills. Note: To comply with US immigration and other legal requirements, it is necessary to specify the minimum number of years' experience required for any role based within the USA. For roles outside of the USA, to ensure compliance with applicable legislation, the JDs should focus on the substantive level of experience required for the role and a minimum number of years should NOT be used.

Responsible for documentation verification, FAT/SAT support, and ensuring accuracy in machine records. Requires IQ/OQ/DQ knowledge, AutoCAD, MS Office, and basic automation, electrical & pneumatics understanding. Required Candidate profile B.E/Diploma in Mechanical/E.C./IC with expertise in AutoCAD, MS Office & technical docs. Skilled in packaging machine docs, IQ/OQ/DQ, automation & pneumatics; precise, detail-driven communicator.

You will be responsible for equipment validation and Quality Management System (QMS) related activities. Your main duties will include the preparation, review, execution, and compilation of validation protocols for in-house Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of all equipment and systems used in Injectable production at the Indore site. Additionally, you will ensure that Periodic Performance Verification (PPV) is conducted and approved according to the PPV schedule. As part of your role, you will be required to manage a team and allocate tasks effectively. You will also oversee the QMS system, including handling change control, deviations, Corrective and Preventive Actions (CAPA) related to validation activities. In case of deviations and non-conformances identified on the shop floor, you will be responsible for conducting investigations and implementing corrective actions and CAPA within the specified timeline. Your commitment to Diversity, Equity, and Inclusion is highly valued in this role.,

Job Description Business: Piramal Critical Care Department: Information Technology Location: Kurla Travel: Low Job Overview To perform and document Computer System Validation of GxP Systems as per defined processes at Central Partner Functions and across Piramal Critical Care sites. Key Stakeholders: Internal Business Site / Central Partner functions IT Team (e.g. SAP / Infra / Quality IT / Allied / SAP etc) Key Stakeholders: External IT Vendors, IT Contractors/Consultants, Piramal CSV Partner Reporting Structure Reports to: AGM IT - CSV Education Qualification & Experience Graduate in Science/Pharmacy/Engineering Post Graduation MPharm/Science/MBA (Desirable) Candidate with 10-14 years of experience in Pharma/Life science domain working on CSV, Part 11/Annex 11, Data Integrity Work experience in Pharma or IT Sector will be desirable Roles & Responsibilities Must have thorough understanding, practical approaches for Computer system validation (CSV) & Computer Software Assurance of enterprise level applications. Accountable to ensure compliance of CSV documentation during various phases (project, operational & retirement) of software lifecycle (SLC).Well aware with GAMP5, CFR Part 11/EU Annex 11 and Data integrity requirements. To create end to end CSV deliverables for IT projects e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. To create QMS documents e.g. Change control/Deviation/Incidents-Discrepancy/User access forms. To perform Root cause analysis and define CAPA based on QMS documents review. To support Quality Automations Initiatives across the Central Partner functions/PCC/PPL sites. To liaise with Site IT , Business SPOCs for CSV activities and IT Compliance initiatives. To guide and train IT & CSV teams (Central Partner Functions & Site) for CSV, and CSV Regulatory Compliance activities. To work along with Business, IT, QeC & Project Manager to ensure project timelines are met. Experience on validation of any of the enterprise level applications. e.g. Track wise, Ensur/Documentum, Paperless Validation Tools, LIMS, LMS, SAP, RIMS Applications, Artwork management Systems, Serialization, Veeva etc. Author, review and approval of SOPs, Guidelines/Policies as applicable. Competencies Good knowledge of 21 CFR Part 11 / Annexure 11 (Must) Good knowledge of CSV, CSA,GAMP 5 Guidelines (Must) Good knowledge of Data Integrity requirements for Pharma (Must) Experience in working with various geographical Location Stakeholders such as US, European, APAC. (Must) Experience of working with Global Pharma Cross functional Sites QC, QA, Manufacturing, IT, SAP etc. (Plus) Experience of validation on automation/digitization projects (Plus) Good Verbal and Written communication skills (Must) Aware of industry best practices and knowledge about Pharma 4.0 (Plus) Functional knowledge of CSV Regulatory guidelines, Quality Control and Manufacturing processes (Plus) Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) 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 Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders. PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators. Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space. Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment. Show more Show less

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. Job Description Roles and Responsibilities Establish and execute project quality plan, witness-points, quality records for compliance with contract. Ensure customer quality requirement, Feedback of Experience (FOE)/Lessons Learned are taken into account to avoid deviation and to continually improve execution processes. Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional strategy. A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations. Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance. Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions. Required Qualifications For roles outside of the USA- This role requires advanced experience in the Quality & QA Engineering. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience). For roles in USA - Bachelor's degree from an accredited university or college (or a high school diploma GED with at least 6 years of experience in Job Family Group(s)/Function(s)). Desired Characteristics Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.Note: To comply with US immigration and other legal requirements, it is necessary to specify the minimum number of years' experience required for any role based within the USA. For roles outside of the USA, to ensure compliance with applicable legislation, the JDs should focus on the substantive level of experience required for the role and a minimum number of years should NOT be used.

About the role The SRM will ensure that business stakeholders manage suppliers in line with risk appetite, optimising post-contract value, and developing a transparently sustainable supply base. The role holder will collaborate closely with senior stakeholders from across FIL to establish broad internal stakeholder relationships, drive value from, and manage risk across the supplier portfolio. These stakeholders include but are not limited to: senior executives across FIL; Supplier Relationship Managers (SRMs) across FIL; Supplier Risk Oversight (Procurement 2LoD function); Senior Procurement Category leaders; and risk partners across FIL. The SRM will be use experience of supplier risk and relationship management to create clear supplier strategies (commercial, contractual and risk) for a defined element of the supplier portfolio, and will ensure the requirements contractual obligations, Procurement policy, and business unit objectives are met and evidenced in regular routines. About you Previous experience as a Supplier Relationship Manager is essential, with at least 3 years SRM FS experience desired. Experience of working within an Enterprise Risk Management framework model, with knowledge of the 3LoD model. It is essential the role holder demonstrate behaviours aligned to FILs Values and Behaviours. It is desirable for the role holder to have sound knowledge of key global regulations pertaining to Outsourcing and controls. Commercial awareness and ability to partner with Procurement to negotiate fees and contracts. Enthusiastic, self-driven and with a high level of self-motivation to overcome obstacles and a strong desire to make things happen. Strong personal presence, excellent interpersonal and communication skills, ability to establish a successful rapport, communicate and influence at all levels. Excellent organisational skills, presentation of reports and attention to detail. Strong decision-making skills. Ability to be flexible and responsive to a constantly changing environment.

About The Role Project Role : Business Process Architect Project Role Description : Analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs. Must have skills : Computer System Validation (CSV) Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Process Architect, you will engage in the analysis and design of innovative business processes. Your typical day will involve collaborating with various stakeholders to create comprehensive documentation that directs the implementation of new processes and technologies. You will work closely with the business to define product requirements and use cases, ensuring that they align with both process and functional needs. Additionally, you will participate in user and task analysis, effectively representing the business's needs to facilitate successful outcomes. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Expected to provide solutions to problems that apply across multiple teams.- Facilitate workshops and meetings to gather requirements and feedback from stakeholders.- Develop and maintain process documentation to ensure clarity and consistency across projects. Professional & Technical Skills: - Must To Have Skills: Proficiency in Computer System Validation (CSV).- Strong analytical skills to assess business processes and identify areas for improvement.- Experience in process mapping and documentation techniques.- Ability to communicate effectively with diverse teams and stakeholders.- Familiarity with project management methodologies to ensure timely delivery of projects. Additional Information:- The candidate should have minimum 12 years of experience in Computer System Validation (CSV).- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

About The Role Project Role : Business Process Architect Project Role Description : Analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs. Must have skills : Computer System Validation (CSV) Good to have skills : NAMinimum 15 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Process Architect, you will engage in the analysis and design of innovative business processes. Your typical day will involve collaborating with various stakeholders to create comprehensive documentation that directs the implementation of new processes and technologies. You will work closely with the business to define product requirements and use cases, ensuring that they align with both process and functional needs. Additionally, you will participate in user and task analysis, effectively representing the business's needs to facilitate successful outcomes. Roles & Responsibilities:- Expected to be a Subject Matter Expert with deep knowledge and experience.- Should have influencing and advisory skills.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Expected to provide solutions to problems that apply across multiple teams.- Facilitate workshops and meetings to gather requirements and feedback from stakeholders.- Develop and maintain process documentation to ensure clarity and consistency across projects. Professional & Technical Skills: - Must To Have Skills: Proficiency in Computer System Validation (CSV).- Strong analytical skills to assess business processes and identify areas for improvement.- Experience in process mapping and modeling techniques.- Ability to communicate complex concepts clearly to diverse audiences.- Familiarity with regulatory requirements related to computer system validation. Additional Information:- The candidate should have minimum 15 years of experience in Computer System Validation (CSV).- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

Role & responsibilities Activities to be performed with the compliance of ISMS requirements by means of confidentiality, integrity, and availability. Data integrity must be followed and ensured in all the respective responsibilities. Audits: Sponsor Audits: Managing the sponsor audits as a whole, from pre requestees to close out meeting. Addressing audit observations within timeline. Follow up sponsors for certificates/clearance. Standard Audits: Ensuring the readiness for Audit. Supporting the cross functions for readiness requirements. Managing the audit from open meeting to close out meeting. Addressing the observations. Vendor Audits: Initiating the vendor qualification process based on requirements. Conducting onsite vendor audits with respect to ISO 9001:2015, ISO27001:2022 or other applicable ISO standards. Assessing the potency of vendors for iVRS service. Issuing audit observations, verification of CAPA and issuance of certificates. Verifying the surveillance audit due dates and initiating the surveillance audits within timeline. Score card updates for vendors. Internal Audit: Conducting Internal audit as per iVRS internal audit SOP, Ensuring the compliance with respect to internal SOPs, regulatory guidelines, etc Issuing the audit reports, verification of CAPA, closing the Audits. MRM: Facilitating the MRM upon completion of Internal audit under MR supervision Requesting cross functional inputs Making the MRM presentation Analytical Development: Develop documentation and system as per Quality Management System and ensure its implementation in the laboratory. Preparation of manuals and policies. To review the Manuals, Standard Operating Procedures, and other quality documents and approval of the same. Review and Approval of study protocols, Validation protocols, Qualification protocols and CSV protocols Review and approval of Validation reports, Qualification reports and CSV execution and reports. Develop, implement, and manage processes to ensure that studies / project activities meet required specifications for quality, function, and reliability prior to submission of data to the sponsor/customer. Review and approve of project / study documents related to analytical department to ensure its compliance with inhouse SOPs, study specific protocols, and applicable regulatory requirements & guidelines. Monitoring and ensure that the lab is following practices/ procedures laid down by way of regular planned and unplanned audits. Customer query- to register the query received from customer and handling the investigations Review, monitoring and data compilation of customer queries. Implementing, maintaining and improving the established analytical lab and in-process processes and methods. Verifying and approving the Laboratory incidents and investigations To oversee the activities with respect to Quality Management Systems and Learning and Development. Verification and approval of calibration documents. Verification of Audit trials in various instruments for validation, study and calibrations. Verification of biannual audit trails Attending all mandatory trainings (as applicable) without fail. Clinical Development: Conduct inspections or test checks to determine if all studies are conducted in accordance with the Principles of Good Clinical Practice Review of protocol and other study related documents Site visits whenever required. QMS: Verification of Procedures for its adequacy, To review and approve master list of SOPs. (as a backup to the designated employee) Preparation of new procedures and revision of existing procedures. Preparation, review, approval of Quality assurance procedures. Review and approval of cross function procedures. Verification, authorization/approval/Closure of Change controls, LIR and other QMS forms. Verification and approval of QMS trending. Review IQ, OQ, PQ records, Calibration certificates and Computer System Validation for Automated Software, as per 21 CFR Part 11 compliance. Ensure to follow and accomplish the Quality Objectives and ISMS objectives. Preparation / Verification of QA and ISMS objectives and actuals, Actuals, Risk assessments, Asset lists, etc Training: Ensuring the annual training schedule. Ensuring the mandatory trainings are conducted as per schedule. Ensuring the identified trainings are conducted for team members. Planning regulatory and QA trainings. Conducting BCP-DRT meetings. Ensuring the surveillance audits and ensuring the internal feedbacks.

Your Role Design and implement SAP solutions tailored to the unique regulatory and operational needs of the life sciences industry. Collaborate with R&D, manufacturing, quality, and compliance teams to align SAP systems with GxP and FDA/EMA requirements. Lead SAP S/4HANA implementations across pharmaceutical, biotech, and medical device domains. Ensure integration of SAP with lab systems (e.g., LIMS), MES, and serialization platforms. Drive digital transformation initiatives focused on traceability, patient safety, and operational efficiency. Your Profile 12-16 years of experience in SAP, with a strong focus on life sciences industry processes and compliance. Expertise in SAP S/4HANA, SAP ATTP (Advanced Track and Trace for Pharmaceuticals), and SAP QM. Proven ability to deliver validated SAP solutions in regulated environments (21 CFR Part 11, GAMP 5). Strong understanding of clinical, manufacturing, and supply chain operations in life sciences. Experience with cloud platforms and integration with digital health or IoT systems is a plus. What you"ll love about working here You can shape yourcareerwith us. We offer a range of career paths and internal opportunities within Capgemini group. You will also get personalized career guidance from our leaders. You will get comprehensive wellness benefits including health checks, telemedicine, insurance with top-ups, elder care, partner coverage or new parent support via flexible work. At Capgemini, you can work oncutting-edge projectsin tech and engineering with industry leaders or createsolutionsto overcome societal and environmental challenges. Location - Hyderabad,Bengaluru,Pune,Mumbai

About The Role We are seeking a skilled and experienced MES Engineer with hands-on expertise inKrber Werum PAS-Xto support manufacturing operations in a regulated pharmaceutical or life sciences environment. The ideal candidate will have a strong technical foundation, validation knowledge, and excellent communication skills to effectively bridge the gap between technical teams and business stakeholders. Key Responsibilities:- MBR Design & Development: Design and create complex Master Batch Records (MBRs) for Weighing & Dispensing, Manufacturing, and Packaging processes. Analyze site-specific requirements and translate them into functional MBRs. Validate MBRs for deployment across manufacturing sites. System Configuration & Administration: Configure and customize Werum PAS-X modules including GMBRs, PVL, PMBRs, Equipment Management, Material Flow, Weigh & Dispense, EBR, and Master Data. Design and developState Diagramsand determine updates forMaster DataandEquipment Management. Integration & Interface Management: Work on SAP-MES interfaces, Level 2 (L2) integrations, and report development. Ensure seamless data flow and system interoperability. Compliance & Validation: Ensure compliance with GxP, GAMP, and 21 CFR Part 11 standards. Participate in validation activities includingIQ/OQ/PQand documentation. Project & Stakeholder Management: Act as an Offshore Lead and manage service delivery for PAS-X. Liaise with clients and stakeholders to gather requirements and provide technical solutions. Provide support forWerum PAS-X installation, upgrade, development, and configuration. Primary Skills (Must-Have): Strong hands-on experience withWerum PAS-X(Specification, Execution, Compliance & Performance Modules). Expertise inMBR creation,State Diagram design, andMaster Data configuration. Experience inPAS-X System Administrationandcustomization. Knowledge ofISA-95/S88 standardsand their application in MES design. Familiarity withSAP-MES integrationandL2 automation systems. Understanding ofpharmaceutical manufacturing processesand regulatory requirements. Secondary Skills (Good-to-Have): Programming knowledge inSQL,C#, andJava. Experience withuser management,system profile creation, andreporting tools. Exposure toITIL frameworksandIT service management. Experience inproject management,client communication, andteam leadership. IT Skills: SQL Queries C# (C-Sharp) Java Experience in: User management System profile creation System configuration and troubleshooting

Deloitte is looking for Deputy Manager | CSV | | SAP to join our dynamic team and embark on a rewarding career journey Assist the Manager in the day-to-day operations of the business, including setting goals, developing strategies, and overseeing the work of team members Take on leadership responsibilities as needed, including managing team members and making decisions in the absence of the Manager Identify and address problems or challenges within the business, and develop and implement solutions Collaborate with other departments and teams to ensure smooth and efficient operations Maintain accurate records and documentation Contribute to the development and implementation of business plans and goals

Role & responsibilities .Department - Production (Fill-Finish) Jr. Operator / Operator / Sr. Operator Job Description: Depyrogenation, HPHV Steam Sterilizer, Production related activities, Lyophilizer, Vial filling & Sealing machine operations & Formulation activities Experience: 1 - 6 years Qualification: ITI/Diploma/B. Sc/Equivalent Job Description: Officer / Executive /Jr Executive Production plan, filling activities, cGMP, SOP, Preventive maintenance, Lyophilizer, Aseptic Media fills, HPHV, Handling Filter integrities, DQ, IQ, PQ, OQ. Experience: 1 - 6 years Qualification B. Pharmacy / M. Pharmacy What should you carry 1. Updated resume 2. Latest increment letter with last three months pay slips Preferred candidate profile

1. Understanding various SDLC (Agile, Waterfall, V) 2. Analyze requirements, perform impact analysis, and regression analysis, and communicate with stakeholders on the need for changes in requirements. 3. Strong experience in Manual and Exploratory Testing. 4. Good experience with various testing types like Functional, Regression, UI/ Usability, Integration testing, etc., 5. Idea on Generative AI for testing 6. Good experience in various testing techniques. 7. Experience in testing and test planning of CI/CD-based solutions through tools like Azure DevOps. 8. Experience in Programming (Java/Python etc.,). 9. Experience in designing automation frameworks (POM, Cucumber BDD, etc.,.). 10. Automate scripts using a given Selenium-based framework and/ Playwright based framework with BDD implementation. 11. Working experience or knowledge of any low-code automation tools. 12. Working experience in testing Restful Webservices and APIs using frameworks or tools like POSTMAN, Rest API, etc. 13. Hands-on experience using ADO or any test management tools. 14. Good exposure to the AWS cloud platform. 15. Experienced working in GXP related implementations 16. Well versed with GxP terminology and having hands-on experience in IQ/OQ/Protocol, Test Plan documents, RTM, OQ Execution, TSR etc.

Ensure accurate and timely processing of invoices and monitor incoming payments. Manage and oversee the daily operations of the AR department including invoice processing, payment processing, and account reconciliation. Knowledge of TDS & GST. Secure revenue by verifying and posting receipts and resolving any discrepancies. Maintain accurate records and control reports for all AR transactions. Use accounting software and MS Excel to process business transactions and compile reports. Collaborate with other departments to ensure billing accuracy. Address and respond to customer inquiries regarding invoices and payments. Ensure compliance with accounting principles and company procedures. Participate in financial audits and implement audit recommendations. Contribute to team efforts by accomplishing related results as needed. Drive operational excellence and continuous improvement in the AR process. Handle refund processes efficiently and effectively. Demonstrate a global mindset and entrepreneurial spirit in all tasks and projects. Foster a culture of people excellence within the team. The candidate should have a strong financial and commercial acumen, with a deep understanding of accounting principles and proficiency in accounting software. The candidate should also have excellent problem-solving skills, be a team player, and have a strong focus on customer service.

As an Advanced Engineer for Process Automation at NNE, you will play a crucial role in providing innovative solutions in life science and pharmaceutical projects. Your responsibilities will include developing functional specifications, coding DCS applications, conducting peer reviews, coordinating with cross-functional teams, testing and verifying functionality, and ensuring commissioning and qualification meet regulatory standards. You will collaborate with a diverse team of engineers across project phases, demonstrate expertise in specific areas, and contribute to technical solutions within and across teams. With a minimum of 5 years of experience in a similar role, you will be part of the Process Automation department at NNE. Your days will involve working in a dynamic team environment, interacting with highly skilled engineers, and engaging in project-oriented tasks on an international scale. The projects you will be involved in range from small revamps to large-scale greenfield production facilities, providing you with opportunities for professional growth and development. To excel in this role, you should be able to work independently, adapt procedures to achieve specific tasks, demonstrate initiative and prioritize effectively. Your ability to make operational decisions, face challenges persistently, and maintain strong communication skills will be essential. A customer-oriented approach, professional ethics, and openness to learning new technologies are qualities we value at NNE. To be considered for this position, you should hold a degree in engineering in Electronics, Instrumentation, Electrical, or Industrial Automation. Knowledge of the 800xA system and other DCS automation systems, along with familiarity with Process Automation System Architecture, ISA S88 Batch, and regulatory requirements, will be advantageous. Experience in integration specifications, test and qualification protocols, as well as FAT, SAT, IQ, and OQ processes, will strengthen your application. At NNE, we are dedicated to shaping the future of pharma engineering by establishing efficient, sustainable, and intelligent facilities crucial for drug production worldwide. If you are ready to unleash your potential and contribute to our values of innovation, initiative, and teamwork, we welcome you to join our passionate team. The deadline for applications is 16th April 2025, and interviews will be scheduled on an ongoing basis. For any inquiries before applying, please contact Akshatha at AZXY@nne.com. Kindly note that applications must be submitted through our online recruitment system to be considered. NNE is committed to an inclusive recruitment process and equality of opportunity for all job applicants. To learn more about us, visit www.nne.com.,