Role & responsibilities
Execute and review process validation, cleaning validation, equipment qualification (DQ, IQ, OQ, PQ) and hold time studies.
Prepare, review and approve validation protocols, reports and SOPs.
Handle Quality Management System (QMS) activities including Deviations, CAPA, Change Control, OOS, OOT, Risk Assessment and investigations.
Perform In-Process Quality Assurance (IPQA) activities during manufacturing, filling, packaging and aseptic operations.
Ensure compliance with cGMP, GLP, GDP, Data Integrity and regulatory requirements.
Manage Computer System Validation (CSV) documentation and lifecycle activities as per GAMP 5 and 21 CFR Part 11.
Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR) and validation documents.




Participate in internal audits, regulatory inspections and customer audits.
Support technology transfer, qualification and validation activities for current products and equipment.
Coordinate with Production, Engineering, QC and Regulatory Affairs for quality compliance.

Preferred candidate profile
Experience in Injectable, Sterile, Vaccine or Biologics manufacturing.
Solid knowledge of regulatory guidelines including USFDA, EU GMP, WHO, MHRA and PIC/S.
Valuable communication and documentation skills.

📌 Qa Executive Assistant Manager Qms, Ipqa, Validation & Csv Hyderabad
🏢 NA
📍 Hyderabad