HEAD OF QUALITY

1. Develop and implement the Quality department’s strategy, to ensure it meets the business requirements and customer deliverables, as well as ensuring the departmental performance against goals. 2. Responsible for the implementation of an effective and dynamic Quality Management System in accordance with CGMP based on PIC/S, ISO, or other international standards, and current technological requirements in pharmaceutical manufacturing and quality control. 3. Acting as the main point of contact on all Quality matters, internally and externally. 4. Ensuring regulatory compliance with all licenses including NPRA. 5. Ensuring the development of effective and complete departmental SOPs (writing, revising, and approving), ensuring regulatory compliance in conjunction with being ‘fit for purpose’ operationally and commercially. 6. Ensuring that all activities are performed in accordance with GMP, company SOPs, and Health and Safety policies. 7. Ensuring that there is an audit, management rewiew and self-inspection program in place which is communicated to Operations to meet the requirements of GMP, ISO, and others. 8. Plan, coordinate and successfully execute validation and re-validation activities. Managing all validation activities, including validation strategy and approval of protocols and reports. 9. Ensuring the availability of adequate competent resources to carry out the review and approval of batch documentation in accordance with GMP requirements. 10. Preparing, reviewing, and approving Technical and Quality Agreements. 11. Ensuring appropriate investigation of discrepancies, errors, complaints, failures, or adverse events requiring documented review and action (if necessary, interrupting processes causing the material to be quarantined or placed on hold until matters are resolved). 12. Leading customer and regulatory audits/inspections and responsible for internal Quality Audit Program, vendor audit program, and third-party audits. 13. Ensuring that the Quality department meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives. 14. Providing direction and guidance to the Quality team. Managing, motivating, coaching, and mentoring direct reports, to higher levels of management capability to ensure effective delivery of the team’s goal. 15. Ensuring good relations and communications with all members of the team and responding politely and in a timely fashion to internal and external customers. 16. To participate in project review meetings for the development of new product formulations and production lines to ensure they are designed and developed to comply with the requirements of Good Manufacturing Practices and Good Laboratory Practices and are conducted in accordance with approved procedures. 17. Prepare monthly summaries and submit reports of quality issues and performance for the Managing Director for presentation to the senior management team. 18. Liaise with internal departments to identify and review the operation flows to enhance overall efficiency and compliance to the quality management system. 19. Responsible to ensure company’s compliance with all the provisions of the applicable Acts, rules, regulations, codes, standards and guidelines and other legislation and standard applicable to the services. 20. Engaging internal and external stakeholders to provide regulatory strategy and support within applicable context. 21. Responsible to maintain close liaison with government officers namely State and Federal Pharmacy Enforcement officers and, National Pharmaceutical Regulatory Agency for all matters pertaining to product registration and regulatory. 22. Responsible for the efficient, effective, accurate and smooth running of the laboratories. 23. Responsible to ensure a fully traceable, retrievable, and testing trial of data including raw data, testing reports, CoAs, for Incoming Control, In Process, Finished Product, Stability Study and all other testing carried out in the department. 24. To ensure concise an up-to-date, retrievable, active documentation system at all times. 25. Responsible to ensure that the production environment and facilities are stable and in adherence to quality standard. 26. Responsible to review batch records and release production batches for use commercially.