Key Responsibilities:


Lead and oversee Quality Assurance (QA) and Quality Control (QC) functions at the API manufacturing facility.
Ensure compliance with cGMP, ICH, WHO, USFDA, and other international regulatory standards.
Manage Quality Systems — change control, deviation, CAPA, OOS/OOT, investigations, and document control.
Review and approve SOPs, specifications, validation protocols, and batch manufacturing records.
Coordinate internal audits, vendor audits, and regulatory inspections; ensure timely closure of audit observations.
Oversee product release and ensure all quality parameters meet regulatory and customer requirements.
Drive continuous improvement initiatives in quality systems and manufacturing processes.
Train and mentor QA/QC teams to enhance compliance culture across the organization.
Liaise with regulatory authorities and external clients for audits, product reviews, and documentation.
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