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Quality Assurance & Regulatory Affairs Role - Pharma (10-20 yrs)
Role - Head Quality Assurance & Regulatory Affairs.
Experience - 10 + Years
Education - M. Pharma (Quality Assurance Technology)
Reporting Authority - Deputy QA Manager/Company Pharmacist
Location - Nairobi (Kenya)
1. Ensure that all products are designed and developed in a way that takes account of the requirement of GMP.
2. Leading Quality Assurance team and managing entire activity of Quality Management System within the Dinlas Pharma EPZ Limited and responsible for international regulatory certification for the Dinlas site.
3. Ensure Team members adhere to GMP, Company Policies and procedure to promote cGMP.
4. Manage Qualification and validation for the entire Dinlas Site.
5. Responsible for all regulatory submission done from Quality department.
6. Responsible for method transfer and method development.
7. Providing IT and ERP related support to the organization.
8. Responsible for collaboration with audit compliance team and checked compliance as per 2I CFR-Part 11, 58, 210, and 820 EU Annex - 11, GAMP - 5
9. Training user management of Lab Instruments as 21 CFR Part 11 and EU - Annex - 11.
10. Responsible for SOPs updation, software audit, GAP assessment review review and performance of all type of testing activities and audit trails.
11. Responsible for Quality and GMP trainer for the organization and scheduling annual training programs.
12. Play lead role during facing regulatory inspection like EAC, NAFDAC, MCC, EU MHRA, WHO - Geneva, TGA etc.
13. Establish a system to handling of market complaints and Product recall, Audit Trails, risk assessment, OOS and OOT.
14. Establish a system for review of quality data and avail the Annual Production Quality Review.
15. Approve Master Batch Sheet documents, specifications, procedures, SOP- s, protocols and reports.
16. Ensure Master documents controls and distribution of Dinlas Pharma EPZ Limited.
17. Implementation of GMP, GLP, GDP, and GEP in the organization.
18. Training to Dinlas team on data governance, data integrity, applicable regulations and control of data governance, data integrity and data retrieval system of the organization.