Executive - Quality Assurance (CSV)
Amneal Pharmaceuticals
Date: 1 week ago
City: Ahmedabad, Gujarat
Contract type: Full time
Job Purpose
JOB DESCRIPTION
To ensure compliance of computerized systems, PLC/SCADA-controlled equipment, and automation systems with regulatory requirements (21 CFR Part 11, EU Annex 11, GAMP 5, etc.) by executing validation activities as per approved procedures and maintaining validated states throughout the system lifecycle.
Key Responsibilities
Validation Planning & Execution:
Develop and maintain validation protocols (URS, DQ, IQ, OQ, PQ, RTM) for computerized systems and PLC/SCADA-controlled equipment.
Execute validation activities in line with cGMP, GAMP 5, and internal SOPs.
Review and approve vendor-supplied documentation (FDS, HDS, SDS, FAT/SAT, etc.).
Compliance & Documentation
Ensure systems comply with 21 CFR Part 11 and data integrity principles.
Maintain proper documentation and traceability of all validation activities.
Prepare validation summary reports and maintain system validation status.
Risk Assessment & Change Management
Conduct risk assessments for new or modified systems and automation projects.
Participate in impact assessments and manage change control for validated systems.
Audit Support & Training
Support internal and external audits (USFDA, MHRA, EU, WHO, etc.).
Provide training and guidance to users and departments on validated systems and data integrity practices.
Coordination & Vendor Management
Coordinate with Engineering, IT, QA, QC, Production, and vendors for validation-related activities.
Monitor vendor performance and ensure timely completion of qualification activities.
Lifecycle Management
Ensure systems remain in a validated state through periodic reviews and re-validation as needed.
Support decommissioning and archival activities as per SOPs.
Key Skills And Competencies
Strong knowledge of CSV principles, GAMP 5, 21 CFR Part 11, and Annex 11.
Familiarity with PLCs, SCADA, HMI, DCS, MES, and Building Management Systems (BMS).
Understanding of pharmaceutical manufacturing processes and regulatory requirements.
Good documentation, analytical, and problem-solving skills.
Effective communication and project coordination abilities.
Qualifications
Qualification: B.Pharma/ M.Pharma/ B.E / B.Tech
Candidate must have 3 - 5 years of relevant experience.
Note: Employee who want to apply for internal job posting must have completed atleast 2 years in his current role.
JOB DESCRIPTION
To ensure compliance of computerized systems, PLC/SCADA-controlled equipment, and automation systems with regulatory requirements (21 CFR Part 11, EU Annex 11, GAMP 5, etc.) by executing validation activities as per approved procedures and maintaining validated states throughout the system lifecycle.
Key Responsibilities
Validation Planning & Execution:
Develop and maintain validation protocols (URS, DQ, IQ, OQ, PQ, RTM) for computerized systems and PLC/SCADA-controlled equipment.
Execute validation activities in line with cGMP, GAMP 5, and internal SOPs.
Review and approve vendor-supplied documentation (FDS, HDS, SDS, FAT/SAT, etc.).
Compliance & Documentation
Ensure systems comply with 21 CFR Part 11 and data integrity principles.
Maintain proper documentation and traceability of all validation activities.
Prepare validation summary reports and maintain system validation status.
Risk Assessment & Change Management
Conduct risk assessments for new or modified systems and automation projects.
Participate in impact assessments and manage change control for validated systems.
Audit Support & Training
Support internal and external audits (USFDA, MHRA, EU, WHO, etc.).
Provide training and guidance to users and departments on validated systems and data integrity practices.
Coordination & Vendor Management
Coordinate with Engineering, IT, QA, QC, Production, and vendors for validation-related activities.
Monitor vendor performance and ensure timely completion of qualification activities.
Lifecycle Management
Ensure systems remain in a validated state through periodic reviews and re-validation as needed.
Support decommissioning and archival activities as per SOPs.
Key Skills And Competencies
Strong knowledge of CSV principles, GAMP 5, 21 CFR Part 11, and Annex 11.
Familiarity with PLCs, SCADA, HMI, DCS, MES, and Building Management Systems (BMS).
Understanding of pharmaceutical manufacturing processes and regulatory requirements.
Good documentation, analytical, and problem-solving skills.
Effective communication and project coordination abilities.
Qualifications
Qualification: B.Pharma/ M.Pharma/ B.E / B.Tech
Candidate must have 3 - 5 years of relevant experience.
Note: Employee who want to apply for internal job posting must have completed atleast 2 years in his current role.
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resumeSimilar jobs
Portfolio Manager-KCC
IDFC FIRST Bank,
Ahmedabad, Gujarat
1 day ago
Job RequirementsRole/ Job Title: Portfolio Manager - KCCFunction/ Department: Rural BankingJob PurposePortfolio Hygiene parameters to ensure no overdue or breach of key portfolio matrices.Portfolio retention and enhancement of exiting limits of customersInterest servicing and regular renewal and review of limits of customersCross-sell of products to KCC customersRoles & ResponsibilitiesManaging KCC Portfolio, ensuring portfolio hygiene - Interest servicing, Churning, Review &...
Technical Support Specialist
Cin7,
Ahmedabad, Gujarat
1 week ago
Cin7 is a fast-growing global software company that provides solutions for modern-day product sellers. We help these sellers keep track of their inventory at scale, and help them sell their products across multiple sales channels around the world.Cin7 is expanding very quickly with a mission to become the leading Inventory Management Software brand in the world, and we are looking...
BA_IT_PythonDeveloper_GCC
Welspun World,
Ahmedabad, Gujarat
1 week ago
About WelspunWelspun World is one of India's fastest growing global conglomerates with businesses in Home Textiles, Flooring Solutions, Advanced Textiles, DI Pipes, Pig Iron, TMT bars, Stainless Steel, Alloy, Line Pipes, Infrastructure & Warehousing.At Welspun, we strongly believe in our purpose to delight customers through innovation and technology, achieve inclusive & sustainable growth to remain eminent in all our businesses....
