Head Quality Assurance (Sterile facility)

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, new 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