Quality Head

Great Pacific Exports; Navi Mumbai; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Great Pacific Exports in Navi Mumbai is seeking a seasoned Quality Head to develop and implement the Quality Department strategy aligned with regulatory requirements. You will oversee QA, QC, and Regulatory Affairs to ensure site readiness for FDA audits and customer inspections.

Responsibilities include maintaining GMP compliance, data integrity, QMS and QRM, leading audits, training teams, monitoring KPIs and budgets, ensuring quality systems across LIMS, MasterControl, ERP, and ensuring

Responsibilities

• Develop and implement the Quality Department strategy aligned with business objectives and regulatory requirements.
• Oversee QA, QC, and Regulatory Affairs to ensure smooth operations.
• Ensure site readiness for regulatory, FDA, and customer audits.
• Maintain GMP compliance with regulatory guidelines, policies, and SOPs.
• Ensure product quality, patient safety, data integrity, and Good Documentation Practices.
• Implement and monitor the Pharmaceutical QMS and Quality Risk Management (QRM).
• Investigate and close deviations, OOS/OOT, market complaints, and CAPA promptly.
• Lead internal and external audits, regulatory inspections, and customer quality audits.
• Provide effective training on GMP and quality systems.
• Monitor KPIs, budgets, costs, and operational efficiency.
• Ensure quality software like LIMS, Chromeleon, MasterControl, and ERP functions properly.
• Oversee laboratory testing, documentation, and timely reporting of results.
• Manage supplier qualification, vendor audits, outsourced activities, and quality agreements.
• Keep regulatory documentation and dossiers updated as required.
• Coordinate management reviews and drive continuous improvement in quality systems.
• Communicate and escalate quality issues to management as needed.
• Ensure pharmaceutical products are consistently manufactured and tested to approved specifications.

Job description

Key Responsibilities

1. Develop and implement the Quality Department strategy in line with business objectives and regulatory requirements.
2. Oversee the smooth functioning of Quality Assurance (QA), Quality Control (QC), and Regulatory Affairs.
3. Ensure continuous site readiness for regulatory, FDA, and customer audits.
4. Maintain compliance with current GMP, regulatory guidelines, company policies, and SOPs.
5. Ensure product quality, patient safety, data integrity, and Good Documentation Practices.
6. Implement and monitor the Pharmaceutical Quality Management System (QMS) and Quality Risk Management (QRM).
7. Ensure timely investigation and closure of deviations, OOS/OOT results, market complaints, and CAPA.
8. Lead internal audits, external audits, regulatory inspections, and customer quality audits.
9. Ensure effective training on GMP, regulatory requirements, and quality systems.
10. Monitor departmental performance, KPIs, budgets, costs, and operational efficiency.
11. Ensure proper functioning and compliance of quality software, including LIMS, Chromeleon, MasterControl, and ERP.
12. Oversee laboratory testing, documentation, and timely reporting of results.
13. Manage supplier qualification, vendor audits, outsourced activities, and quality agreements.
14. Ensure regulatory documentation, drug master files, and dossiers are updated as required.
15. Coordinate management reviews and promote continuous improvement in quality systems and processes.
16. Ensure effective communication and escalation of quality issues to management.
17. Ensure pharmaceutical products are consistently manufactured and tested according to approved specifications and quality standards.
18. Follow company HR, Quality, Environment, Health, and Safety policies and maintain workplace discipline.