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Key Responsibilities:

- Ensure compliance with cGMP, GLP, FDA and regulatory requirements.
- Lead QC team operations, daily task allocation and technical troubleshooting.
- Review analytical raw data, HPLC/GC audit trails, SOPs and batch release documents.
- Lead investigations related to OOS, OOT, deviations and incidents, including RCA and CAPA.
- Manage stability studies, instrument calibration, analytical method validation/transfer and cleaning verification.
- Maintain reference standards and laboratory documentation.
- Train and guide QC analysts and reviewers.
- Coordinate with QA, Production and Regulatory Affairs for quality-related activities.
- Support regulatory inspections and maintain audit readiness.

Technical Skills:

- Hands-on experience with HPLC, GC, UV-Vis and wet chemistry.
- Solid knowledge of QMS, QRM, GMP and laboratory compliance.
- Working knowledge of SAP Laboratory modules.
- Experience facing USFDA / EDQM / ANVISA audits is mandatory.
- Microbiology knowledge will be an added advantage.
- Good written and verbal English communication skills.

📌 Assistant Manager / Deputy Manager - Quality Control (Bharuch)
🏢 SDP HR Solution
📍 Bharuch