Implementation Manager Jobs Opening in Sun Pharmaceutical Industries Limited at Vadodara
FEATURED JOBTechnical Validation Engineer
organization.
Job Description
Key Responsibilities
Validation Documentation: Author and execute standard validation lifecycle documents including User Requirements Specifications (URS), Functional Specifications (FS), and Risk Assessments. [1, 2]
Protocol Execution: Write and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) test protocols. [1]
Compliance & Data Integrity: Ensure system adherence to regulatory standards (e.g., FDA 21 CFR Part 11, EU Annex 11, and GAMP 5) and data integrity principles (ALCOA+). [1, 2, 3]
Lifecycle Management: Manage change controls, system deviations, and Corrective and Preventive Actions (CAPAs) for validated systems.
Audit Readiness: Maintain traceability matrices and act as a CSV representative during internal and external regulatory inspections
