Job Description
Key Responsibilities:
• Lead and manage the QC department including Analysts, microbiologists, and lab
technicians.
• Oversee analytical testing for raw materials, in-process samples, finished products, and
stability studies.
• Approve release decisions for batches in accordance with specifications and SOPs.
• Maintain compliance with cGMP/cGLP, PIC/S guidelines and local regulatory
requirements.
• Develop and implement QC SOPs, test methods, and validation programs. Support best
practices in Laboratory in terms of integrity, accuracy and adequacy of the testing and
documentation.
• Manage laboratory quality systems: deviation handling, CAPA, change control,
OOS/OOT investigations, and documentation control.
• Coordinate regulatory inspections and supplier audits; prepare QC for site visits and
responses.
• Drive continuous improvement in test turna...
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