Role & responsibilities
- Develop, implement, and maintain the Quality Management System (QMS).
- Ensure compliance with GMP, ISO standards, SOPs, and regulatory requirements.
- Review and approve SOPs, Batch Manufacturing Records (BMR), Batch Packing Records (BPR), specifications, and quality documents.
- Monitor in-process quality activities and ensure adherence to approved procedures.
- Investigate deviations, customer complaints, OOS (Out of Specification) results, and non-conformities, and implement CAPA.
- Conduct internal audits and coordinate customer, regulatory, and certification audits.
- Review and approve change controls, risk assessments, and validation protocols/reports.
- Ensure qualification and validation of equipment, processes, utilities, and cleaning procedures.
- Oversee vendor qualification and quality evaluation of raw materials and packaging materials.
- Coordinate with Production, QC, R&D;, Warehouse, and Regulatory teams for smooth operations.
- Monitor quality KPIs and prepare periodic quality reports for management review.
- Lead and mentor the QA team through regular training and performance monitoring.
- Ensure document control and record retention as per regulatory requirements.
- Drive continuous improvement initiatives to enhance product quality and process efficiency.
- Ensure timely product release in compliance with approved quality standards.
Preferred candidate profile
- Master's degree in Pharmacy, Chemistry, Microbiology, Biotechnology, or a related Life Sciences discipline.
- 8-12 years of experience in Quality Assurance within the Pharmaceutical or Cosmetics Manufacturing industry.
- Minimum 35 years of experience in a managerial role.
- Solid knowledge of GMP, GLP, GDP, ISO 22716, and regulatory requirements.
- Excellent understanding of QMS, CAPA, Change Control, Deviations, and Risk Management.
Location-Faridabad Interested candidates can share their cv at
[email protected]
📌 Quality Assurance Manager (Ballabhgarh)
🏢 Wings Pharmaceuticals
📍 Ballabhgarh