Qc Manager

Role & responsibilities

• Lead and manage QC laboratory operations for biotechnology and fermentation processes.
• Oversee testing of raw materials, media, fermentation broth, intermediates, and finished products.
• Monitor fermentation parameters and in-process quality attributes in coordination with Production/Process teams.
• Manage microbiological testing, including microbial identification, bioburden, contamination monitoring, and sterility-related testing.
• Oversee biochemical and analytical testing such as pH, moisture, protein, assay, biomass, and other product-specific parameters.
• Ensure proper sampling, testing, documentation, and release of materials and products.
• Handle OOS, OOT, deviations, investigations, CAPA, and change controls related to QC.
• Establish and review specifications, analytical methods, SOPs, protocols, and test procedures.
• Ensure qualification, calibration, and maintenance of laboratory equipment.
• Ensure compliance with GMP, GLP, biosafety, data integrity, and ALCOA+ principles.
• Lead method validation, verification, analytical method transfer, and process-related testing.
• Prepare and coordinate the QC function for internal, customer, and regulatory audits.
• Manage QC personnel, training, workload, and laboratory performance.
• Coordinate closely with Production, QA, R&D, Fermentation, and Process Development teams.

Preferred candidate profile

• Strong experience in Biotechnology / Fermentation QC.
• Knowledge of Microbiology and Fermentation Technology.
• Experience with microbial culture, contamination control, media testing, and microbial analysis.
• Knowledge of HPLC, GC, UV-Vis, FTIR, pH meter, spectrophotometer, and other relevant analytical instruments.
• Understanding of fermentation process monitoring and in-process controls.
• Knowledge of GMP, GLP, OOS/OOT, CAPA, deviations, and data integrity.
• Experience in laboratory documentation and regulatory compliance.
• Strong team management, troubleshooting, and problem-solving skills.