Job Description

1. Responsible for overseeing quality assurance operations within the aseptic area, ensuring compliance with established standards and regulatory requirements. 2. The role involves utilizing previous experience to supervise and manage quality procedures in sterile or aseptic environments. 3. Collaborating with teams to maintain and enhance quality assurance processes while identifying and addressing areas for improvement. 4. Contributing to the development and implementation of quality policies and procedures specific to aseptic areas. 5. Collaborate with operational functions and the QA team to define audited processes and systems. 6. Develop an internal audit plan for GMP activities concerning finished product quality, adhering to internal protocols, standard procedures, and regulatory guidelines. 7. Issue timely audit observations and reports, ensuring follow-up until closure. 8. Apply a risk-based approach to determine audit scope. 9. Evaluate and oversee corrective and preventive action plans within specified timelines to address audit findings and prevent recurrence. 10. Monitor and ensure timely responses to internal audits as per defined schedules, tracking progress to meet commitment dates. 11. Create clear, concise, and evidence-based audit reports for effective communication of findings. 12. Identify significant audit issues and propose suitable recommendations. 13. Offer guidance and advice on quality, compliance, and efficiency matters. 14. Consult operational teams on quality-related concerns. 15. Maintain accurate and timely documentation of QA auditing activities. 16. Manage pre-inspection activities and act as the QA lead during health authority inspections, facilitating responses, commitments, and timely communication of findings. 17. Identify avenues for continuous improvement. 18. Generate and distribute monthly reports on outstanding internal audit commitments. 19. Stay updated on regulatory, quality, and industry developments pertinent to GXP..

Requirements:

- 7 years’ experience in QA-pharmaceutical. - Extensive experience as an internal auditor in QA. - At least three (3) years in QA supervisory role. - Particularly in sterile manufacturing of drug products by Aseptic Fill-Finish process. - Fluency in English.