General Manager & Head Quality Assurance (Sterile facility)

Immacule Life Sciences; Solan; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Immacule Life Sciences is seeking a Senior QA Leader to head the Quality Assurance function for its Sterile Injectable Facility in India. The role requires driving cGMP compliance, establishing a robust QMS, and leading audits, investigations, and quality improvements across aseptic processing, manufacturing, and release of finished products.

The ideal candidate will oversee regulatory inspections, data integrity, and CAPA programs while steering technology transfer, new product introductions,

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, specs, 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.

Job description

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.