Assistant General Manager, QC Lab at Amneal India

Sarkhej, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

25 Sep, 26

Salary

0.0

Posted On

27 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

QC Analytical Management, Peptide Characterization, Sterile Injectables, Analytical Method Validation, Regulatory Compliance, Stability Program Management, Data Integrity, LC-MS, HPLC, UPLC, LIMS, CAPA, OOS/OOT Investigation, GMP Compliance, Method Transfer, Audit Readiness

Industry

Pharmaceutical Manufacturing

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 --------------------------------------------------------------------------------

Responsibilities

Lead and manage the QC Chemical department for sterile injectables and peptide-based formulations, overseeing the full analytical lifecycle from raw materials to finished products. Ensure strict adherence to global regulatory guidelines and maintain data integrity across all laboratory systems.