Job Description
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 au...