Role & responsibilities
- Overall responsibility for GMP compliance and the Pharmaceutical Quality Management System (PQMS).
- Establish, implement, and monitor quality policies, procedures, SOPs, and quality standards.
- Review and approve BMR/BPR, specifications, protocols, reports, and other quality documents.
- Ensure proper handling of deviations, OOS/OOT, CAPA, change controls, and investigations.
- Review and approve batch records and product release as per approved specifications.
- Oversee validation and qualification of processes, equipment, cleaning, and systems.
- Manage market complaints, product recalls, and mock recalls.
- Plan and conduct internal audits and coordinate customer/regulatory inspections.
- Ensure compliance with GMP, GDP, data integrity, and applicable regulatory requirements.
- Monitor vendor qualification and quality agreements where applicable.
- Ensure effective training and GMP awareness of employees.
- Review quality trends, risk assessments, and periodic quality reports.
- Coordinate with QC,



Production, Warehouse, Engineering, and Regulatory Affairs on quality matters.
- Promote continuous improvement and a strong quality culture throughout the organization.

Preferred candidate profile
- B.Pharm/M.Pharm/M.Sc. in Pharmacy, Chemistry, or related discipline.
- 15 to 18 years of experience in Pharmaceutical QA, with managerial experience preferred.
- Solid knowledge of GMP, GLP, GDP, Data Integrity, and regulatory requirements.
- Hands-on experience in QMS, deviations, CAPA, change control, OOS/OOT, and risk management.
- Experience in batch release, validation, audits, inspections, and product complaints/recalls.
- Solid leadership, decision-making, analytical, and problem-solving skills.
- Excellent documentation, communication, and team-management skills.
- Ability to ensure regulatory compliance and continuous quality improvement.

📌 Quality Assurance Manager (Neemrana)
🏢 Glowria Lifecare
📍 Neemrana