Head Qa Qc

Job Summary

We are looking for an experienced and dynamic Head QA/QC to lead Quality Assurance and Quality Control operations for pharmaceutical and medical device products. The candidate will be responsible for ensuring product quality, regulatory compliance, quality management systems, and audit readiness in accordance with cGMP, GLP, ISO 13485, EU MDR, and applicable regulatory guidelines.

Role & responsibilities

• Lead overall QA/QC operations and ensure compliance with applicable regulatory requirements.
• Manage the Quality Management System (QMS), SOPs, documentation control, and quality compliance.
• Oversee batch release, deviations, CAPA, OOS/OOT investigations, and change control.
• Manage QC laboratories, including chemical, instrumental, and microbiological testing.
• Ensure calibration, qualification, and maintenance of analytical instruments.
• Lead regulatory, customer, and third-party audits and ensure timely closure of audit observations.
• Oversee medical device Design & Development documentation, including DHF, DMR, and Technical Files.
• Coordinate with Regulatory Affairs, Production, and R&D teams to maintain product quality and compliance.
• Develop and implement quality policies, procedures, and continuous improvement initiatives.
• Lead, mentor, and develop QA/QC teams and conduct GMP, GLP, and data integrity training.

Preferred candidate profile

• B. Pharm, M. Pharm, M.Sc. in Chemistry, Microbiology, or a relevant pharmaceutical/science discipline.
• 12 to 15+ years of relevant experience in QA/QC within the pharmaceutical or medical device industry.
• Strong knowledge of cGMP, GLP, ISO 13485, EU MDR, ICH guidelines, and regulatory requirements.
• Experience in handling regulatory audits, quality systems, documentation, and team management.
• Excellent leadership, analytical, problem-solving, and communication skills.