Head Quality Assurance
1 day ago
Job Title: Head Quality Assurance
Division / Department: Quality / Quality Assurance
Reporting To: Management
Team Size: 23
Role Type: Function Head Single Business Line
Job Overview:
We are looking for an experienced and quality-driven Head Quality Assurance to lead the QA function at our pharmaceutical manufacturing facility . The role is responsible for ensuring full compliance with cGMP, Schedule M, and international regulatory standards across OSD (Tablets, Capsules, Dry Syrups) and Semi-Solids/Topicals (Creams, Gels, Ointments). The position will champion a strong quality culture and audit readiness across the site.
Key Responsibilities:
- Lead the Quality Assurance function and ensure robust QMS governance (Deviation, OOS, CAPA, Change Control, Market Complaints).
- Maintain compliance with national and international regulatory bodies (CDSCO, WHO-GMP, MHRA, etc.).
- Prepare for and lead audits/inspections, ensuring timely and effective CAPA implementation.
- Manage batch review, QA documentation, training on GMP/GDP/Data Integrity, and batch release protocols.
- Support new product introductions, validation, and technology transfers from a QA perspective.
- Conduct risk assessments (QRM) and lead site-wide continuous improvement initiatives.
- Collaborate cross-functionally with Production, QC, Engineering, SCM, and EHS to ensure quality alignment.
Qualifications & Experience:
- Bachelor's or Master's in Pharmacy, Chemistry, or a related field.
- 12 to 18 years of experience in pharmaceutical QA; minimum 5 years in a leadership capacity.
- Strong expertise in regulatory compliance, QMS, audit management, and documentation control.
- Proven leadership in building quality culture and driving site-wide compliance initiatives.
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