Job 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.

• End-to-end QC Analytical lifecycle for sterile injectables and peptide formulations

• Advanced peptide characterization techniques (LC-MS, UPLC, impurity mapping)

• Regulatory compliance under global health authorities (USFDA, EMA, MHRA)

• Analytical method development, validation, and transfer lifecycle

• Stability program design and statistical trend evaluation

• Data integrity systems and electronic laboratory compliance (LIMS/CDS)

• Cross-functional coordination in sterile manufacturing environment

Exposure

Individual will gain exposure in the following areas:

Audit preparedness and regulatory inspection management

• 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.

• Strong experience in sterile injectable or peptide manufacturing environment preferred