Site Quality Head (DGMGM) API Site

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.

Ideal Candidate Profile:

• 15 years of experience in pharmaceutical quality functions with hands on QA and QC Heading in API site
• Strong knowledge of API manufacturing and regulatory requirements
• Proven leadership and team management skills
• Passion for excellence and patient-centric outcomes