48 Gamp Jobs - Page 2

Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our employees, our customers and our communities. The Role Are you passionate about delivering exceptional service and revolutionizing the world of technology? We have an incredible opportunity for a talented individual to join our dynamic team as a Plant IT Operations Lead. In this customer-centric role, you will play a pivotal role in ensuring our customers receive top-notch service within a contractual framework. As a visionary leader, you will inspire and guide our team of experts to deliver high-quality and reliable information technology services. Working closely with the latest systems, software products, and networked devices, you will align our solutions perfectly with our customers' evolving business needs. Your deep knowledge of the services we provide paired with your understanding of customer businesses, will enable you to propose and implement tailored solutions that exceed their expectations. You will be an integrated part of our customer account structure, fostering strong relationships with our customers and collaborating closely with our Delivery Partner & Customer Partner. Together, you will create an environment that promotes innovation, collaboration, and customer success. By owning the technical and managerial support for our plant IT team, field engineers, technicians, system administrators, subject matter experts, and product support personnel, you will empower them to deliver, manage, maintain, and deploy IT services effectively. When troubleshooting incidents, problems, changes, and escalations, you will be at the forefront, providing swift support to fix any issues that may arise in malfunctioning services, operations, software, or equipment. Your expertise will ensure that our systems run smoothly, offering our customers a seamless experience. As a plant operations Lead, you will have the unique opportunity to collaborate with an exceptional team of Delivery Partners, Architects, and SREs (Site Reliability Engineers). You will co-create, design, deploy, and maintain reliable, available, and future-proof systems and services. Your innovative ideas and leadership skills will play a vital role in shaping the technological landscape of our organization and the industry as a whole. If you are ready to make an impact, drive customer success, and be at the forefront of technological advancements, this is the role for you. Join our team and be part of an exhilarating journey as we reshape the IT services landscape with creativity, passion, and excellence. Your Future at Kyndryl Kyndryl has a global footprint, which means that as a Delivery Management Lead at Kyndryl you will have opportunities to work on projects and collaborate with colleagues from around the world. This role is dynamic and influential – offering a wide range of professional and personal growth opportunities that you won’t find anywhere else. Who You Are You’re good at what you do and possess the required experience to prove it. However, equally as important – you have a growth mindset; keen to drive your own personal and professional development. You are customer-focused – someone who prioritizes customer success in their work. And finally, you’re open and borderless – naturally inclusive in how you work with others. Required Skills and Experience Over 12 years of experience leading delivery teams and providing quality services to customers. Pervious experience in working with Pharma will be advantageous Strong understanding of Kyndryl competencies, managed platforms, IT services, and technology vendors. Strong understanding and knowledge of Pharam Plant IT Operations Oversee the day-to-day operations of IT infrastructure, network, applications, and support services. Ensure high availability and performance of critical systems including MES, LIMS, ERP, and SCADA. Ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 11, GAMP 5, GxP). Collaborate with QA/Compliance teams to support audits and inspections. Maintain cybersecurity posture in line with corporate standards and industry best practices. Lead and mentor a team of IT professionals and support staff. Manage IT budgets, contracts, and vendor relationships. Work closely with cross-functional teams including manufacturing, QA/QC, engineering, and supply chain. Experienced in leading teams through incident, problem, and change management, as well as root cause analysis. Capable of partnering with Delivery Partners and collaborating with SREs to achieve positive customer outcomes. Hands-on knowledge of AIOps with an automation and innovation-focused mindset. Proficient in maintaining direct and ongoing interaction with customers. • Compassionate and empowering delivery resource manager, promoting growth Knowledge of IT/OT systems, industrial networking, and cybersecurity in manufacturing. Preferred Skills and Experience •Bachelor's degree •Six Sigma, PMP, and/or ITIL certifications Being You Diversity is a whole lot more than what we look like or where we come from, it’s how we think and who we are. We welcome people of all cultures, backgrounds, and experiences. But we’re not doing it single-handily: Our Kyndryl Inclusion Networks are only one of many ways we create a workplace where all Kyndryls can find and provide support and advice. This dedication to welcoming everyone into our company means that Kyndryl gives you – and everyone next to you – the ability to bring your whole self to work, individually and collectively, and support the activation of our equitable culture. That’s the Kyndryl Way. What You Can Expect With state-of-the-art resources and Fortune 100 clients, every day is an opportunity to innovate, build new capabilities, new relationships, new processes, and new value. Kyndryl cares about your well-being and prides itself on offering benefits that give you choice, reflect the diversity of our employees and support you and your family through the moments that matter – wherever you are in your life journey. Our employee learning programs give you access to the best learning in the industry to receive certifications, including Microsoft, Google, Amazon, Skillsoft, and many more. Through our company-wide volunteering and giving platform, you can donate, start fundraisers, volunteer, and search over 2 million non-profit organizations. At Kyndryl, we invest heavily in you, we want you to succeed so that together, we will all succeed. Get Referred! If you know someone that works at Kyndryl, when asked ‘How Did You Hear About Us’ during the application process, select ‘Employee Referral’ and enter your contact's Kyndryl email address.

Candidate must have hands on experience in Werum PAS-X/FTPS development. Candidate shall work with end user team to establish requirement specifications e.g. URS, FRS Support the team in the business process mapping, requirements analysis, scope definition. Responsible for creating and revising batch records Extensive software Design, Develop, Commission, and Validate MES applications using MES platforms primarily on Siemens OpcenterTM, experience on other MES system such as Rockwell FTPS, Emerson SyncadeTM MES and/or Werum PAS/XTM, Aspentech, Rockwell etc. will be added advantage. Act as a Subject Matter Expert for Design and Development of workflows, and various MES components such as EBMR, Document Management, Material Management, Training, and Equipment Tracking and Monitoring. Device interface mechanism with various software packages such as Laboratory Information Management System (LIMS), Quality Management Systems (QMS), and PAT etc. Lead cross functional meetings to gather requirements, scope, and business rationale for MES projects. Facilitate design review workshops with process subject matter experts. Offer remote support to overseas projects. Communicate proactively with peers, customers, and management - highlighting and resolving issues, proposing solutions and driving project to completion. Excellent problem solving and analytical skills Conduct training and share knowledge with team members Position requirements: Professional Experience: Experience of design, development, and deployment experience in SIMATIC IT eBR will be preferred, experience on other MES system like Rockwell FTPS, Emerson Syncade, Werum PAS/X MES, Aspentech, and/or Rockwell etc. will be added advantage. Thorough understanding of ISA S88 and S95 models. Knowledge of Pharmaceutical manufacturing process will be an added advantage. Hands-on experience on Distributed Control Systems such as PCS 7, Emerson DeltaV or similar will be an added advantage. Knowledge of Computer Systems Validation, SDLC methodologies and GAMP is must. Excellent written and verbal communication skills. Ability to work within a team, lead cross-functional teams, and work independently in dynamic environments. Willingness to travel for startup and commission activities Key Skills: FTPS, Emerson Syncade, Werum PAS/X MES, Aspentech ISA S88 and S95 models Distributed Control Systems such as PCS 7, Emerson DeltaV Computer Systems Validation, SDLC methodologies and GAMP LIMS, QMS and PAT

** VEDIO CALL INTERVIEW ** Roles and Responsibilities Perform CSV (Computer System Validation) tasks for new systems implementation. Ensure compliance with GMP regulations during software validation processes. Conduct software validation activities according to GAMP guidelines. Key Skills : Good Exposure on CSV,PLC, Software Validation in pharmaceutical industry, SAP,LIMS Qualification, TRIMS,NICHELONS,HVACMS/BIMS,EMPOWER,ELMS. ** Preferred male candidate only. Interested candidate can share their resumes below mail id: sonali.n@hetero.com/9100408534. Job Location : Unit V, Hetero Labs limited, Jadcherla, Hyderabad.

Primary Function of Position The EQMS Business Analyst will be responsible for identifying, developing and implementing software solutions. This will include working with process owners to identify continuous improvement opportunities and develop software solutions to support process effectiveness and efficiencies. Individual will also be accountable for managing projects and software throughout their respective lifecycles. Essential Job Duties Directly participate in the analysis, configuration, modifying and implementation of IT Business Systems Demonstrate good communication, analytical and problem-solving skills to help identify, communicate and resolve system issues in order to maximize the benefit of IT systems Analyze the effectiveness and efficiency of existing business processes and business requests, and recommend solutions using system standards and best practices Conduct analysis of system specifications, configurations and develop appropriate documentation Create detailed specifications and process flows to provide direction to application developers Perform solution designing, requirements definition, functional design, testing and implementation of IT solutions Support, assist and train the users on new modified system configurations highlighting the impact on business processes Maintain IT Business system integrity and application notes, system upgrades, changes, and user updates Work closely with onsite team, off shore team, managers and executives to ensure the release of high quality solutions Comply with regulatory and change control requirements and processes #LI-Hybrid Qualification Required Skills and Experience Minimum 5 years of TrackWise System Analysis experience Experience in Medical Device manufacturing industry and systems regulations (21 CFR Part 11, GxP, GAMP, etc.) and good understanding of CAPA and Complaints processes Perform business requirements gathering, requirements analysis, business system design, installation, configuration, user testing and validation support of TrackWise based applications. Java Programming: Strong knowledge and experience in Java programming, including Java 8 features and beyond. Frameworks: Proficiency in Java frameworks such as Spring, Hibernate, and Apache Struts for building and maintaining applications. Web Technologies: Understanding of web technologies like HTML, CSS, and JavaScript, along with frameworks like Angular or React. Database Management: Experience with database management systems (DBMS) like MySQL, Oracle, or MongoDB, including SQL queries and database design Create workflows, Business rules, TWC automation, Notifications and Migrate updates. Create TrackWise WebServices(Search/Populate/Transfer) using OWS/IWS. Create and Implement Crystal Reports Exposure to integration with SAP ERP and CRM systems preferred Familiarity with Software Development Lifecycle (SDLC) processes Good verbal and written communication skills Ability to work on multiple projects concurrently. Ability to work with minimum supervision or guidance Should contribute in team building measures like Knowledge Management & Mentoring Required Education and Training Minimum education: Bachelor's or undergraduate degree in Computer Science, Information Systems or equivalent experience Preferred Skills and Experience Trackwise & Trackwise Digital experience preferred Additional Information ${jobpostDetails.jobAd.sections.additionalInformation.text }

Experience in CSV, GAMP, GXP, 21CFR, Part11. Experience in Documentation Writing Good Communication skills. NP - Immediate to 15 Days Mode - Remote

ABOUT THE ROLE You will play a key role in a regulatory submission content automation initiative which will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation. The initiative leverages state-of-the-art technologies, including Generative AI, Structured Content Management, and integrated data to automate the creation, review, and approval of regulatory content. ?? Role Description: We are seeking an experienced Validation Engineer to work on a GxP platform supporting the automation of regulatory filings. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records of test plans, test cases, and test results to ensure traceability and compliance. Validate test scenarios against feature acceptance criteria and customer expectations. Ensure system compliance with regulatory requirements for data integrity, traceability, and reliability. Identify opportunities to enhance testing efficiency and minimize manual efforts. Evaluate and adopt tools and technologies to improve automation capabilities. Keep validation documentation updated and aligned with GxP standards. Ensure strict adherence to change management processes for validated systems. Stay informed on industry trends, emerging technologies, and regulatory updates relevant to GxP. Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, troubleshooting, and improving new and existing applications and platforms. Basic Qualifications and Experience: Master’s degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Functional Skills: Must-Have Skills: Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology Experience with Agile software development methodologies (Scrum) Excellent communication skills and the ability to interface with senior leadership with confidence and clarity Experience in writing requirements for development of modern web application Strong understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11. Proficiency in automation tools, data systems, and validation software. Good-to-Have Skills: Demonstrated expertise in a scientific domain area and related technology needs Understanding of scientific software systems strategy, governance, and infrastructure Familiarity with low-code, no-code test automation software Technical thought leadership Able to communicate technical or complex subject matters in business terms Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications : SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Expertise in computer system validation, QMS and IT Compliance. Good understanding of GAMP 5, 21 CFR Part 11, Annex 11, ICH Q9. Validation experience and expertise in manufacturing, QC, Investigation, CAPA, Deviati

Role - CSV Consultant Exp - 4+ Years Skills - CVS , CAPA, Gamp, Gxp, SAP / LIMS / LABWARE Permanent: Harjai Computers Pvt.LTD Location: Mumbai Work location - WFO Mode of working- 5 days, Monday to Friday Interview Mode - VC round

We are looking for a determined and dedicated Lead Engineer for ProcessAutomation who can provide innovative solutions in complete life science andpharmaceutical projects. This also includes understanding the clients complexprocess facilities, with Good Automated Manufacturing Practice (GAMP) regulatedrequirements for a pharmaceutical production facility. Our department consistsof dedicated engineers, specialized in different phases of the project including Conceptual Design, Basic Design, Detailed Design, Commissioning andQualification. Experience: Minimum 8+ years How you might spend your days As Lead Engineerfor Process Automation, you'll be working with a motivated, multi-functionalteam where youll be: Responsible for deliverables where output is Complex in a specific area such as: Leading an area with a team Setting direction, planning, execution & handover. Understanding various Project phases and automation deliverables for the same. Supervising / Development of functional specifications of Complex Units. Supervising / Developing DCS Application coding based on programming standards and design guidelines. Performing SME/Lead reviews to ensure consistency. Co-ordination and alignment with cross-functional teams i.e. Process/Mech. & E/I Team Co-ordination and alignment with Operational IT system. Testing and Verification to ensure that programming or coding is meeting functionality. Commissioning and Qualification to ensure that systems and equipment meet the requirements of end-users and regulatory agencies with multi-discipline collaboration. Ensuring project's technical and validation concepts are shared with team and are revisited on a regular basis. Handling Change management & impact assessment for the same. Acting as Subject Matter Expert in own discipline. Sharing lessons learnt and contribute to continuous improvement. Acting as mentor / coach to juniors. Making decisions that impact own team and possibly other teams or operational areas. Who you are At NNE,we care about who you are as a person. In the end, how you work, and yourenergy is what impacts the work we do as a team. As a person, you are: Able to perform work independently, handle complex challenges and apply specialist knowledge when adapting solutions. Able to identify better practice and improve procedures, processes, tools, equipment, or techniques based on industry specific knowledge & business experience. Able to take initiative, prioritize, and plan for own work and/or team to reach deadlines. Able to make decisions under conditions of uncertainty, proactive in identifying roadblocks. Able to drive team towards milestone achievements. Able to Challenge solutions and Stakeholders whenever required to align with Standards. Having a positive approach and can be persistent when facing challenges. Customer-oriented and focused with strong professional ethics. Excellent in communication skills and a strong mentor. The miles youve walked. To applyfor the position there are some things that are needed, and others are a bonus.We believe these qualifications are needed for you to do well in this role: Have a degree in engineering in Electronics/Instrumentation/ Electrical/Industrial Automation or similar technical field. You have at least a minimum experience of 8 years in a similar field with proven track record of leading a team. Proficient in 800xA system (Control Builder , SFC, Hardware/Software), other system libraries or any other DCS automation systems. Knowledge of PCDL, PCEL libraries would be an added advantage. Good understanding of Process Automation System Architecture, ISA S88 Batch & good engineering practice. Good knowledge on pharma life cycle /processes, GAMP, 21CFR, GDP & regulatory knowledge would be preferable. Strong Design/ functional specifications (Control Module, EM and Phase class) experience & application development for recipes would be preferable. Experience in Integration Specs, Installation packages, Test and Qualification protocols including test plans would be preferable. FAT, SAT, IQ and OQ experience.

Good knowledge of 21 CFR Part 11 / Annexure 11 (Must) Good knowledge of CSV,GAMP 5 (Must) Good knowledge of Data Integrity requirements for Pharma (Must) Experience of working at Pharma Site QC,QA,IT,CSV Experience in Authoring all CSV deliverables

Job Description: IT Manager, Pharmaceutical Manufacturing Company Job Summary: The IT Manager is a critical role responsible for the overall planning, organization, and execution of all IT functions within our pharmaceutical manufacturing environment. This position ensures the reliability, security, and efficiency of our IT infrastructure, applications, and systems, while adhering to regulatory requirements (e.g., GMP, GAMP 5, 21 CFR Part 11). The IT Manager will lead a team of IT professionals and collaborate with cross-functional departments to support the company's strategic objectives. Responsibilities: Strategic Planning & Leadership: Develop and implement IT strategies aligned with the company's business goals and regulatory requirements. Lead and manage the IT department, including recruitment, training, performance management, and team development. Provide strategic guidance and recommendations on technology solutions to improve operational efficiency and compliance. Manage IT budgets and resources effectively. Infrastructure Management: Oversee the design, implementation, and maintenance of the company's IT infrastructure, including servers, networks, databases, and storage systems. Ensure high availability, reliability, and security of IT systems. Manage and support manufacturing systems (e.g., MES, ERP, LIMS) in a GMP environment. Plan and execute system upgrades and migrations. Manage and maintain all computer systems used in the manufacturing and laboratory environments. Regulatory Compliance & Security: Ensure compliance with relevant regulations and standards, including GMP, GAMP 5, 21 CFR Part 11, and data privacy regulations. Develop and implement IT policies, procedures, and SOPs to maintain compliance and security. Conduct regular IT audits and risk assessments. Manage IT security measures, including firewalls, intrusion detection systems, and data encryption. Manage the validation of computerized systems. Application Management & Support: Manage and support critical business applications, including ERP, MES, LIMS, and other manufacturing-related systems. Collaborate with business users to identify and resolve application issues. Manage software licensing and vendor relationships. Oversee the development and implementation of custom applications as needed. Disaster Recovery & Business Continuity: Develop and implement disaster recovery and business continuity plans. Conduct regular backups and recovery tests. Ensure data integrity and availability in the event of a disaster. Vendor Management: Manage relationships with external IT vendors and service providers. Negotiate contracts and ensure service level agreements are met. Evaluate and select new IT vendors and technologies. Project Management: Manage IT projects from initiation to completion, ensuring projects are delivered on time and within budget. Coordinate with internal and external stakeholders to ensure project success. Document project plans, progress, and outcomes. Help Desk and End User Support: Oversee the help desk function, ensuring timely and effective support to end users. Maintain documentation of IT issues and resolutions. Ensure the proper function of all computers, printers, and other end user devices. Qualifications: Bachelor's degree in Computer Science, Information Technology, or a related field. Minimum 5 years of experience in IT management, preferably in a pharmaceutical manufacturing environment. Strong knowledge of GMP, GAMP 5, 21 CFR Part 11, and other relevant regulations. Experience managing and supporting manufacturing systems (e.g., MES, ERP, LIMS). Proven experience in IT infrastructure management, network administration, and cybersecurity. Excellent leadership, communication, and interpersonal skills. Strong project management skills. Experience with computer system validation. Experience with Cloud computing environments is a plus. Experience with data integrity best practices. Preferred Qualifications: Relevant certifications (e.g., PMP, ITIL, CISSP). Master's degree in a related field. Skills: IT infrastructure management Network administration Cybersecurity GMP/GAMP 5/21 CFR Part 11 compliance Manufacturing systems (MES, ERP, LIMS) Project management Vendor management Budget management Leadership and team management Problem-solving and analytical skills Excellent written and verbal communication. To Apply: Please submit your resume and cover letter to hr@gsbpl.com

Position Overview: We are seeking a knowledgeable and results-driven CSV Engineer to join our team, specializing in providing expert validation services to our clients. In this role, you will work closely with a diverse range of companies, ensuring the compliance, reliability, and quality of their computerized systems while adhering to industry regulations and best practices. Key Responsibilities: Validation Strategy and Planning: - Collaborate with clients to develop tailored validation strategies and plans based on their specific needs and regulatory requirements. - Assess project scope, goals, and timelines to design efficient validation approaches. Validation Execution: - Design, develop, and execute validation protocols, including IQ, OQ and PQ to verify system functionality and compliance. - Provide on-site or remote assistance during testing and data collection phases. Documentation and Reporting: - Generate comprehensive validation documentation, such as validation master plans, Risk assessment/GxP Assessment, FS, CS, FRA, test scripts, 21 CFR PART 11 Assessment and validation reports. - Create clear and organized documentation that demonstrates compliance and traceability. Change Control and Risk Management: - Collaborate with clients to assess and manage risks associated with changes to computerized systems, ensuring proper change control procedures are followed. - Advise on the impact of changes and recommend appropriate validation strategies. Regulatory Compliance: - Stay up-to-date with relevant regulations, guidelines (e.g.,21 CFR PART 11, EU Annexure 11, cGMP, GAMP5, Data Integrity etc.), and industry trends related to computer system validation. - Apply your expertise to guide clients in meeting regulatory requirements during the validation process. Client Collaboration: - Build strong working relationships with clients, acting as a trusted advisor and validation expert. - Provide guidance, recommendations, and regular updates to ensure successful validation outcomes. Training and Support: - Provide training to Perfect Utilities engineers involved in the validation process, empowering them to understand and implement validation principles. Continuous Improvement: - Offer insights and suggestions for process improvement and optimization within the validation lifecycle. Required Qualifications and Candidate Profile: Diploma, Bachelors Degree or equivalent in technical area preferred 1-5 years of hands-on experience in computer system validation of PLC based complex system preferably across different industries and systems. Knowledge of BMS, DCS, Lab Software Validation, Vision Software Validation. Being familiar with validation principles, regulatory requirements (e.g., 21 CFR PART 11, EU Annexure 11, cGMP, GAMP5, Data Integrity etc.) Proven track record of delivering successful validation projects and ensuring compliance. Excellent communication and interpersonal skills to collaborate effectively with diverse clients. Candidate should be ready for travelling across India. Benefits: As a valued member of our team, you will enjoy the opportunity to work with a range of clients, contribute to their success, and expand your professional network. We offer competitive compensation, a dynamic and supportive work environment, and the chance to make a meaningful impact in the industry by delivering exceptional validation services. If you are a skilled CSV Engineer with a passion for assisting companies in achieving compliance and reliability in their computerized systems, we invite you to join us. Help us provide top-notch validation expertise and contribute to our clients' growth and success.

CSV Overall, 10 + Yrs. of experience in SAP CSV Validation Services. Developing validation strategies and plans for SAP implementations, upgrades, and modifications to ensure compliance with regulatory requirements. Conducting System GMP impact assessment, GAMP category assessment, ERES applicability assessment, Requirement/ Functional risk assessment after establishing communication with relevant stakeholders. Conducting change assessments and impact analyses to identify mandatory validation deliverables. Collaborating with cross functional teams, including IT, Business Process, CSV and Quality Assurance to ensure alignment on validation deliverables. Creation, execution, documentation, and review of validation plan, including FDS, BDS, TDS, test plan/ scripts, IQ/OQ/PQ Protocols, Traceability Matrix, validation reports and Release notification (Go Live). Support in defect management/ discrepancy investigation if any as part of the validation deliverables. Providing guidance and support to project teams on validation best practices and compliance requirements. Submit the complete Change/Incident/Project documentation with evidences for review and approvals by the business/quality teams. Upon acquiring all approvals, shall communicate to the development/transport/Basis teams to deploy the change/incident/project in Production environment. Ensure the change/incident/project in Production environment is deployed without any deviations. Participating in validation related meetings, training sessions. Participate in Governance reviews, status reporting and handling of escalations Keeping abreast of industry trends, regulatory changes, and best practices related to CSV in SAP. Contributing to the continuous improvement of validation processes and procedures within the organization. Support during Client Visit and Regulatory inspections.

Role & responsibilities: - Responsible for Computer System Validation (CSV) of laboratory instruments and computerized systems in compliance with GxP, 21 CFR Part 11, and EU Annex 11 regulations. - Lead CSV activities for lab systems (HPLC, GC, TOC, LIMS, CDS, ELN, Empower). - Prepare validation documents: URS, Risk Assessment, IQ/OQ/PQ, Traceability Matrix, Summary Reports. - Ensure compliance with data integrity (ALCOA+) and Part 11 electronic records/e-signature r requirements. - Collaborate with QA, IT, and vendors for validation planning and execution. - Support system change controls, re-validation, and periodic reviews. - Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11. - Experience with lab systems/software validation. - Excellent documentation and communication skills.

Project Role : Tech Delivery Subject Matter Expert Project Role Description : Drive innovative practices into delivery, bring depth of expertise to a delivery engagement. Sought out as experts, enhance Accentures marketplace reputation. Bring emerging ideas to life by shaping Accenture and client strategy. Use deep technical expertise, business acumen and fluid communication skills, work directly with a client in a trusted advisor relationship to gather requirements to analyze, design and/or implement technology best practice business changes. Must have skills : Computer System Validation (CSV) Good to have skills : Life Sciences Minimum 2 year(s) of experience is required Educational Qualification : BE Summary :As a Tech Delivery Subject Matter Expert in Business Process Architecture, you will be responsible for driving innovative practices into delivery, bringing depth of expertise to a delivery engagement. Your typical day will involve using your expertise in Computer System Validation (CSV) to analyze, design and/or implement technology best practice business changes, while working directly with clients in a trusted advisor relationship to gather requirements. Roles & Responsibilities: Lead the analysis, design and/or implementation of technology best practice business changes using your expertise in Computer System Validation (CSV). Collaborate with cross-functional teams to ensure successful delivery of projects. Provide subject matter expertise to clients and internal teams on Computer System Validation (CSV) and related topics. Stay updated with the latest advancements in Life Sciences and related technologies, integrating innovative approaches for sustained competitive advantage. Professional & Technical Skills: Must To Have Skills:Expertise in Computer System Validation (CSV). Good To Have Skills:Knowledge of Life Sciences. Strong understanding of business process architecture and related technologies. Experience in collaborating with cross-functional teams. Excellent communication and interpersonal skills. Additional Information: The candidate should have a minimum of 2 years of experience in Computer System Validation (CSV). Qualification BE

Required Skills: • Resource with 2 -8 years of Relevant experience in Computerized System Validations of Enterprise applications (SAP/LIMS/TrackWise etc.), Equipment and Instrument validations (Manufacturing, Packaging, QC equipment/instruments and Serialization etc.). • Experience in Preparation and Execution of CSV deliverables (IQ, OQ and PQ). • Exposure in Assessment, Review and Preparation of 21 CFR part 11, EU annex 11 Compliance Assessment/Report. • Review of User, Error, Audit Trail records. • Skilled in Risk Assessment for Equipment/Instrument Operations. • Experience in Handling of QMS events (Change control, Deviation, RCI and CAPA). • Experience in Handling of end to end project CSV activities (is an added advantage). Technical Skills required: • Knowledge on handling of ValGenesis Application. • Hands on instrumentation, semi automation or automation • Worked on different layers of automation systems • Knowledge of IT- Operations, data and security management, backup & restore activities, • Exposure to maintenance, troubleshooting of GxP systems, • Understanding of technical & procedural risk assessment and actions. Soft skills (behavioral) required: Self-learner, Team player, Good Communication and Coordination with CFT etc. Any other specification / Requirement: • B. Tech, B.E. B.Sc. – Instrumentation /Electronics/ IT /B. Sc. (Computer Science) having knowledge of SAP, TrackWise, MES, BMS, EMS etc. • B. Pharmacy with exposure in regulation, analytical instrumentation, exposure to production activities along with exposure to latest software LIMS, HPLC etc. Experience Range: 2 to 8 years in Engineering, Consultancy, IT, CSV in Pharma domain

Description Talent with Lifesciences domain experience with Manual testing and GxP testing skills Named Job Posting? (if Yes - needs to be approved by SCSC) Additional Details Global Grade B Level To Be Defined Named Job Posting? (if Yes - needs to be approved by SCSC) No Remote work possibility No Global Role Family To be defined Local Role Name To be defined Local Skills Manual tester with GXP life science Languages RequiredENGLISH Role Rarity To Be Defined

CSV Overall, 10 + Yrs. of experience in SAP CSV Validation Services. Developing validation strategies and plans for SAP implementations, upgrades, and modifications to ensure compliance with regulatory requirements. Conducting System GMP impact assessment, GAMP category assessment, ERES applicability assessment, Requirement/ Functional risk assessment after establishing communication with relevant stakeholders. Conducting change assessments and impact analyses to identify mandatory validation deliverables. Collaborating with cross functional teams, including IT, Business Process, CSV and Quality Assurance to ensure alignment on validation deliverables. Creation, execution, documentation, and review of validation plan, including FDS, BDS, TDS, test plan/ scripts, IQ/OQ/PQ Protocols, Traceability Matrix, validation reports and Release notification (Go Live). Support in defect management/ discrepancy investigation if any as part of the validation deliverables. Providing guidance and support to project teams on validation best practices and compliance requirements. Submit the complete Change/Incident/Project documentation with evidences for review and approvals by the business/quality teams. Upon acquiring all approvals, shall communicate to the development/transport/Basis teams to deploy the change/incident/project in Production environment. Ensure the change/incident/project in Production environment is deployed without any deviations. Participating in validation related meetings, training sessions. Participate in Governance reviews, status reporting and handling of escalations Keeping abreast of industry trends, regulatory changes, and best practices related to CSV in SAP. Contributing to the continuous improvement of validation processes and procedures within the organization. Support during Client Visit and Regulatory inspections.

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. About The Role : The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and documentation to support system compliance and audits. The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. They develop and execute validation protocols (IQ, OQ, PQ), perform risk assessments, and maintain compliance documentation. Primary Skills Bachelors or Masters degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous Skills (competencies)

To support our extraordinary teams who build great products and contribute to our growth, were looking to add a/an Software Validation Engineer - IT located in Chennai Location. Reporting to the Manager and the role involves What a typical day looks like: Good Experience in executing Medical industries software validations, having led and managed projects. Strong working knowledge of applied statistics, quality systems, and regulatory requirements across multiple health authorities including 21 CFR 820, 21 CFR Part 11, ISO 14971, ISO 13485, FDA, EU Medical Device Regulation, GAMP, GPSV, and CSV/CSA High-level strategic problem-solving and reasoning skills. Analyzes evaluates and presents information concerning findings, trends with IT in business, and development. Ensure adherence to software validation processes and perform review & approval for all the software validation activities. Suggests and debates to implement the right SDLC, software validation methods, and procedures with Flex. Train and coach project team members on achieving quality in project deliverables (e.g. GDP, V&V Process, CSV, project-related risks management, resolving the issues by following the right process, and SOP requirements). Conducts meetings (technical & management) to review investigation findings related to IT systems. Cooperates with other department personnel and peers in understanding needs and identifying opportunities for improvements. Serve as the SME for CSV, maintaining the knowledge and information in the CSV area of expertise. Perform software validation activities Liaise between IT, Quality, Project Team, Corporate Quality team, and various regulatory bodies. Keep abreast of regulatory developments within or outside of the company as well as evolving best practices in compliance control. Prepare reports for senior management and external regulatory bodies as appropriate. Escalate non-compliance with a resolution for the fundamental CSV compliance issues. Support the project team to perform audit readiness and project audits. Expected to travel (domestic/internationally) when needed to meet with Flex facility project Teams. Work collaboratively with different departments located in a different geography. The experience were looking to add to our team: 5 - 10 years of experience in Medical/Life Sciences industries software validation and compliance reviews. Strong working knowledge of applied statistics, quality systems, and regulatory requirements across multiple health authorities including 21 CFR 820, 21 CFR Part 11, ISO 14971, ISO 13485, FDA, EU Medical Device Regulation, GAMP, GPSV, and CSV/CSA High-level strategic problem-solving and reasoning skills. Analyzes evaluates and presents information concerning findings, trends with IT in business, and development. Ensure adherence to software validation processes and perform review & approval for all the software validation activities. Suggests and debates to implement the right SDLC, software validation methods, and procedures with the Flex.

Joining timelines: immediate to 1 month Candidate should have a minimum of 8+ years overall Experience Relevant should be at least 2-3 years with lead exp Should have extensive experience in Test documenation like Test Plan, RTM, Test Strategy, Test Data, Bug Report, Test execution report including Test Case creation, and Defect Handling (severity Vs priority) Hands-on experience in Validation test plan, Validation test strategy Validation test documentation, and guiding Should have strong experience in Manual Testing Experience in Test case execution and Bug fixes. should be ready to work as individual contributor too along with Lead role. Experience in Test management tools (Jira and ALM),Knowledge of DB testing Expertise in performing different types of testing like Functional Testing, System Testing, Regression Testing. good to have :Life science or Clinical Trail Domain Experience Working in an Agile environment. We also offer: o Group Health Insurance covering family of 4 o Term Insurance and Accident Insurance o Paid Holidays & Earned Leaves o Paid Parental LeaveoLearning & Career Development o Employee Wellness

Skill required: Quality Governance & Services - Operational Audit & Compliance Designation: Quality Assurance Analyst Qualifications: BE/Bachelor of Pharmacy/Bachelors of Information Technology Years of Experience: Minimum 2 Years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.You will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsThe Operational CSV team focuses on validation of computerized system applications and effective implementation and delivery of functional processes within operations to mitigate risks. The role may require for you to have a good understanding of software tools, GAMP Gudiance, 21 CFR and EU Regulations and hands experience on Validation of Enterprise applications What are we looking for? Information Management System Testing and Validation Adaptable and flexible Ability to meet deadlines Ability to establish strong client relationship Prioritization of workload Problem-solving skills Life Sciences Automation Enablement Life Sciences CSV Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Responsible for supporting and/or conducting validation efforts for Accenture projects. These projects include system implementation, development of non-commercially available systems, deployment of managed hosted systems, validation of systems, and decommissioning of systems. Responsible for project management of the effort. Responsible for authoring or coordinating the authoring of applicable documentation to ensure adherence to current FDA regulations and industry standards: test scripts/checklists (IQ/OQ/UAT), Requirements Specification, Traceability Matrix, System Validation Master Plan, Final Validation Report, etc. Responsible for participating in and contributing to team meetings and fostering knowledge exchange within the Validation Team and with other colleagues. Responsible for mentoring more junior members of the Validation Team. Qualifications BE,Bachelor of Pharmacy,Bachelors of Information Technology

Project Role : Tech Delivery Subject Matter Expert Project Role Description : Drive innovative practices into delivery, bring depth of expertise to a delivery engagement. Sought out as experts, enhance Accentures marketplace reputation. Bring emerging ideas to life by shaping Accenture and client strategy. Use deep technical expertise, business acumen and fluid communication skills, work directly with a client in a trusted advisor relationship to gather requirements to analyze, design and/or implement technology best practice business changes. Must have skills : Computer System Validation (CSV) Good to have skills : Life Sciences Minimum 2 year(s) of experience is required Educational Qualification : BE Summary :As a Tech Delivery Subject Matter Expert in Business Process Architecture, you will be responsible for driving innovative practices into delivery, bringing depth of expertise to a delivery engagement. Your typical day will involve using your expertise in Computer System Validation (CSV) to analyze, design and/or implement technology best practice business changes, while working directly with clients in a trusted advisor relationship to gather requirements. Roles & Responsibilities: Lead the analysis, design and/or implementation of technology best practice business changes using your expertise in Computer System Validation (CSV). Collaborate with cross-functional teams to ensure successful delivery of projects. Provide subject matter expertise to clients and internal teams on Computer System Validation (CSV) and related topics. Stay updated with the latest advancements in Life Sciences and related technologies, integrating innovative approaches for sustained competitive advantage. Professional & Technical Skills: Must To Have Skills:Expertise in Computer System Validation (CSV). Good To Have Skills:Knowledge of Life Sciences. Strong understanding of business process architecture and related technologies. Experience in collaborating with cross-functional teams. Excellent communication and interpersonal skills. Additional Information: The candidate should have a minimum of 2 years of experience in Computer System Validation (CSV). Qualification BE