General Manager – Quality Assurance (Sterile Injectables)

Immacule Lifesciences; Solan; On-site; INR 350,000 - 550,000; Full time

Job summary

Immacule Lifesciences in Nalagarh, Himachal Pradesh, seeks a Head / General Manager – Quality Assurance (Sterile Injectables) with 18+ years of experience. You will lead the QA function, ensure cGMP, USFDA/EU GMP compliance, and drive inspection readiness. The role covers QA governance, aseptic processing oversight, CAPA, deviations, and continuous improvement at a USFDA-approved facility.

MD/PharmD? No, the qualification is B.Pharm/M.Pharm/M.Sc.

Qualifications

• Minimum 18+ years experience in pharmaceutical Quality Assurance.
• Mandatory experience in sterile injectable manufacturing at a USFDA-approved facility.
• Proven track record of independently handling USFDA and other international regulatory inspections.
• Strong expertise in aseptic processing, Media Fill, contamination control, CCS and EU GMP Annex 1.
• Experience leading the complete site QA function with large QA teams.

Responsibilities

• Lead the entire site Quality Assurance function ensuring regulatory compliance and quality governance.
• Establish, implement and strengthen the site QMS.
• Provide QA oversight of aseptic processing, sterile manufacturing, environmental monitoring and validation activities.
• Ensure compliance with USFDA 21 CFR, EU GMP Annex 1, WHO-GMP and ICH guidelines.
• Oversee audits, deviations, CAPA, change controls, complaints and recalls.

Skills

Quality Assurance

Regulatory inspections

USFDA compliance

Aseptic processing

Leadership

Education

B.Pharm/M.Pharm/M.Sc.

Job description

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.

• 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.
• Strong 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.