Description

Key Responsibilities

- Lead and manage the QC Chemical (Analytical) department for sterile injectable and peptide-based formulations.

- Oversee analysis of Raw Materials, In-Process Samples, Finished Products, Stability Samples, and Packaging material samples as per pharmacopoeial and validated methods.

- Ensure development, validation, transfer, and life-cycle management of analytical methods (HPLC, UPLC, GC, UV, Dissolution, KF, IC, LC-MS for peptide characterization).

- Handle peptide-specific analytical testing including:

- Peptide purity & impurity profiling

- Molecular weight confirmation (LC-MS)

- Sequence-related impurity evaluation

- Aggregation studies and degradation profiling

- Review and approve analytical protocols, reports, specifications, and standard testing procedures (STPs).

- Ensure compliance with regulatory guidelines such as ICH, USP, EP, IP, USFDA, EMA, MHRA, WHO.

- Lead stability program management (long-term, accelerated, and in-use studies) and trend evaluation.

- Ensure proper calibration, qualification, and maintenance of analytical instruments (HPLC, GC, FTIR, UV, TOC, Karl Fischer, etc.).

- Drive data integrity compliance (ALCOA+ principles) across QC systems and electronic data systems (LIMS,



CDS, etc.).

- Review and approve OOS, OOT, and laboratory deviations; lead investigations and CAPA implementation.

- Coordinate with QA, Manufacturing, Regulatory Affairs, and R&D; for timely product release and compliance adherence.

- Ensure audit readiness and support regulatory inspections (USFDA, EMA, MHRA, WHO, and client audits).

- Monitor laboratory operations for GMP compliance, safety, and productivity improvements.

- Lead method transfers activities from R&D; to QC for peptide and injectable products.

- Develop and maintain QC departmental SOPs, specifications, and working instructions.

- Ensure timely release of RM, PM, in-process, and finished product reports to support production timelines.

- Drive continuous improvement initiatives in analytical workflows and laboratory efficiency.

Qualifications

- M.Sc. (Chemistry / Analytical Chemistry / Organic Chemistry) or M.Pharm / B.Pharm with Minimum 16–20 years of relevant experience in QC Analytical function in pharmaceutical industry.

- Robust experience in sterile injectable or peptide manufacturing environment preferred

📌 Manager, QC Laboratory (Ahmedabad)
🏢 Important Business
📍 Ahmedabad