Location: Nelamangala Industrial Area, Bengaluru
Industry: Sterile Pharmaceutical Manufacturing
Experience: 5–8 Years in Sterile QA Validation
Qualification: B.Pharm / M.Pharm / B.Sc. / M.Sc.
CTC: ₹6–7.5 LPA (Based on Expertise)
Leadership Role in Sterile Validation
Lead validation activities for a USFDA/EU-GMP sterile injectable plant, ensuring compliance and mentoring junior teams.
Key Responsibilities
✔ Own end-to-end validation (Protocol drafting to report approval) for:
- Equipment (Vial filling lines, Lyophilizers)
- HVAC (Grade A/B areas), Autoclaves, SIP/CIP systems.
✔ Ensure regulatory readiness for USFDA/WHO audits.
✔ Lead deviations, CAPA, and change control management.
✔ Train juniors on GMP documentation and compliance.
Mandatory Requirements
Education: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Life Sciences).
Experience:
- 5+ years in sterile injectable validation (vial/BFS lines mandatory).
- Hands-on with qualification of sterile processes (media fills, aseptic simulations).
Skills: - Expertise in 21 CFR Part 11, EU Annex 1, PDA TRs.
- Proven track record in regulatory inspections (USFDA, EU).
- Leadership in QMS tools (Veeva, TrackWise).
Why Join?
Impact: Directly influence plant compliance and quality.
Global Standards: Implement PDA/ISPE guidelines.
Career Growth: Transition to QA Manager/Validation Lead.
How to Apply
Email: recruitment@avsymphonicsolutions.com
Subject: “Sr. QA Validation Executive @ Bengaluru – [Your Years of Exp]”
Attach: Resume with validation project details, CTC details.