Quality Assurance Manager

Job description:

Job Description: QA Manager Ayurvedic Medicine Manufacturing

Job Title: Quality Assurance (QA) Manager
Department: Quality Assurance
Reports To: Plant Head / Head – Quality

Job Summary

The QA Manager is responsible for developing, implementing, and maintaining the Quality Management System (QMS) to ensure the consistent production of safe, effective, and high-quality Ayurvedic medicines. The role ensures compliance with GMP, regulatory guidelines, and internal quality standards.

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS).
• Ensure compliance with Ayurvedic GMP requirements, applicable regulations, and company SOPs.
• Review and approve Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), specifications, protocols, and reports.
• Review and release or reject raw materials, packaging materials, intermediates, bulk products, and finished products.
• Oversee documentation control and ensure Good Documentation Practices (GDP).
• Conduct internal audits and support regulatory inspections and customer audits.
• Investigate deviations, out-of-specification (OOS) results, customer complaints, and product recalls.
• Implement and monitor Corrective and Preventive Actions (CAPA).
• Manage change control, risk assessments, and quality improvement initiatives.
• Ensure qualification and validation activities (equipment, utilities, processes, cleaning, and computerized systems where applicable).
• Monitor environmental and hygiene standards within manufacturing and warehouse areas.
• Coordinate with Production, Quality Control, Warehouse, Procurement, and Regulatory Affairs departments.
• Conduct training programs on GMP, SOPs, data integrity, and quality systems.
• Review Annual Product Quality Reviews (APQR/PQR) and quality metrics.
• Ensure vendor qualification and supplier audits.
• Maintain compliance with licensing authorities and support product registrations.

Required Qualifications

• Bachelor's or Master's degree in Pharmacy (B.Pharm/M.Pharm), Ayurveda (BAMS), Chemistry, Microbiology, Biotechnology, or a related life science discipline.
• Additional certification in GMP, Quality Management, or Regulatory Affairs is an advantage.

Experience

• 5–10 years of experience in Quality Assurance within the pharmaceutical, Ayurvedic, herbal, or nutraceutical manufacturing industry.
• At least 3–5 years in a managerial or leadership role.
• Experience with GMP audits and regulatory inspections is preferred.

Required Skills

• Strong knowledge of Ayurvedic GMP requirements and quality systems.
• Knowledge of validation, qualification, deviation management, CAPA, change control, and risk management.
• Good understanding of documentation practices and data integrity principles.
• Leadership and team management skills.
• Excellent analytical and problem-solving abilities.
• Effective communication and interpersonal skills.
• Proficiency in Microsoft Office