Job Purpose

Lead the Quality Assurance function for Sterile Manufacturing by ensuring compliance with cGMP, regulatory requirements, Quality Management Systems (QMS), and quality standards while driving continuous improvement and audit readiness.

Key Responsibilities
Lead and maintain the Quality Management System (QMS) across the plant.
Ensure compliance with cGMP, regulatory guidelines, SOPs, and data integrity requirements.
Review and approve quality documents, validation protocols/reports, BMR/BPR, PQR/APR, stability data, and master documents.
Approve batch disposition and release finished products.
Lead investigations related to deviations, OOS/OOT, complaints, recalls, and ensure effective CAPA implementation.
Review and approve Technology Transfer documents and oversee recent product introductions.
Monitor validation, qualification, calibration, and preventive maintenance compliance.
Lead internal, external, vendor, customer, and regulatory audits and ensure timely closure of observations.




Review trend analysis and communicate critical quality issues to Management and Regulatory Authorities.
Approve vendor qualifications, technical agreements, and external testing laboratories.
Ensure GMP compliance for recent facilities, utilities, equipment, and projects.
Lead, develop, and optimize the QA team while ensuring effective resource utilization.
Ensure compliance with EHS, hygiene, and environmental standards.

Experience

18+ Years in Pharmaceutical Quality Assurance with significant experience in Sterile/Injectable manufacturing.

Qualification

M.Pharm / B.Pharm / M.Sc. or equivalent.

Key Competencies
Sterile Manufacturing & Aseptic Processing
QMS & Regulatory Compliance
Validation & Qualification
Batch Release
Investigation & CAPA
Audit Management
Data Integrity
Leadership & Team Management

📌 Deputy General Manager Quality Assurance Sterile Nalagarh
🏢 Immacule Lifesciences
📍 Nalagarh