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.
- Strong knowledge of regulatory guidelines including USFDA, EU GMP, WHO, MHRA and PIC/S.
- Good communication and documentation skills.

📌 QA-Executive - Assistant Manager (QMS, IPQA, Validation & CSV) (Hyderabad)
🏢 NA
📍 Hyderabad