Role & responsibilities

- Lead the entire Quality Assurance function for the Sterile Injectable Facility, ensuring compliance with cGMP and applicable regulatory requirements.

- Establish, implement, and continuously strengthen the site Quality Management System (QMS) and quality governance framework.

- Lead QA oversight of aseptic processing, sterile manufacturing, environmental monitoring, contamination control, and microbiological controls in coordination with relevant functions.

- Ensure effective implementation of quality policies, SOPs, documentation practices, data integrity, and GMP standards across the facility.

- Review and approve critical quality documents including BMR/BPR, MFR, SOPs, specifications, protocols, reports, PQR/APQR, stability data, and validation documents.

- Ensure timely review and release of finished products in accordance with approved specifications and regulatory requirements.

- Lead regulatory, customer, internal, vendor, and contract manufacturing audits, including inspection readiness and timely closure of observations.

- Lead investigations related to deviations, OOS/OOT, incidents, complaints, recalls, and sterility/aseptic-related events, ensuring effective CAPA.

- Review and approve validation, qualification, change control, risk assessment,



cleaning validation, process validation, and computerized system validation activities.

- Provide QA leadership for technology transfer, recent product introduction, facility expansion, and new project activities.

- Ensure robust implementation of Contamination Control Strategy (CCS) and applicable sterile manufacturing requirements.

- Monitor product quality trends, stability programs, CAPA effectiveness, quality metrics, and compliance status.

- Lead vendor qualification, technical agreements, contract manufacturing oversight, and external laboratory approval activities.

- Ensure compliance with calibration, preventive maintenance, hygiene, safety, and GMP requirements.

- Lead QA manpower planning, recruitment, capability development, succession planning, and performance management.

- Ensure effective governance of QA computerized systems, access controls, and data integrity requirements.

- Provide timely escalation of significant quality, compliance, and regulatory risks to senior management.

- Drive a strong quality culture, patient-centric approach, compliance mindset, and continuous improvement across the facility.

Preferred candidate profile

📌 Head Quality Assurance (Sterile facility) (Nalagarh)
🏢 Immacule Life Sciences
📍 Nalagarh