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.
Robust 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.
Valuable written and verbal English communication skills.