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 robust 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.
Robust 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.
Robust 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 (India)
🏢 Glowria Lifecare
📍 India