Head / General Manager – Quality Assurance (Sterile Injectables)

Experience:
18+ Years Qualification: B.
Pharm / M.
Pharm / M.
Sc. Industry: Pharmaceutical – Sterile Injectables Facility: USFDA-Approved Manufacturing Facility Reporting To: Site Head
- Quality

Location:
Nalagarh, Himachal Pradesh Job Purpose To lead the overall Quality Assurance function of the sterile injectable facility, ensuring compliance with cGMP, USFDA, EU GMP and other applicable international regulatory requirements. Drive quality governance, aseptic manufacturing compliance, inspection readiness, product quality, and continuous improvement. Key Roles & Responsibilities
• Lead the entire site Quality Assurance function, ensuring regulatory compliance and effective quality governance.
• Establish, implement and continuously strengthen the site Quality Management System (QMS).
• Provide QA oversight of aseptic processing, sterile manufacturing, environmental monitoring, microbiological controls and contamination control.
• Ensure compliance with USFDA 21 CFR, EU GMP Annex 1, WHO-GMP and applicable ICH guidelines.
• Review and approve critical quality documents, including BMR/BPR, MFR, SOPs, specifications, PQR/APQR, stability and validation documents.
• Ensure timely batch record review, product disposition and finished product release.
• Lead USFDA, EU GMP, customer, internal and vendor audits, ensuring inspection readiness and effective closure of observations.
• Oversee deviations, OOS/OOT, CAPA, change controls, complaints, recalls and quality risk management.
• Provide QA oversight for process validation, cleaning validation,



equipment qualification, CSV and facility qualification.
• Ensure effective implementation and periodic review of Contamination Control Strategy (CCS), Media Fill and aseptic process qualification.
• Drive quality oversight of technology transfer, new product introduction, facility expansion and project activities.
• Monitor product quality trends, stability programs, CAPA effectiveness and site quality KPIs.
• Lead vendor qualification, external laboratory approvals, technical agreements and contract manufacturing oversight.
• Ensure data integrity, computerized system compliance and adherence to ALCOA+ principles.
• Lead QA manpower planning, recruitment, training, capability development and succession planning.
• Drive a strong quality culture, patient safety mindset and continuous improvement across the facility. Educational Qualification B.
Pharm / M.
Pharm / M.
Sc. in Microbiology, Chemistry or relevant discipline. Experience & Competencies
• Minimum 18+ years of experience in pharmaceutical Quality Assurance.
• Mandatory experience in sterile injectable manufacturing at a USFDA-approved/inspected facility.
• Proven track record of independently handling USFDA and other international regulatory inspections.
• Solid expertise in aseptic processing, Media Fill, contamination control, CCS and EU GMP Annex 1.
• Experience in leading the complete site QA function and managing large QA teams.
• Exposure to Lyo, PFS, ophthalmic and oncology injectable manufacturing will be preferred.
• Strong leadership, regulatory decision-making, analytical and stakeholder management skills.

📌 General Manager – Quality Assurance (Nalagarh)
🏢 Immacule Lifesciences
📍 Nalagarh