Quality Assurance Manager

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.
• Strong 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 rhythma.bhatia@wingspharma.com