Key Responsibilities:-
Administer and develop the following elements of the Pharmaceutical Quality System:
1. Product Quality Reviews
2. Technical/Quality Agreements
3. Self-Inspection
4. Customer Complaints
5. Second-level Batch Record reviews
6. Creation of Certificates of Conformity and Certificates of Analysis (including regulatory requests)
7. Ordering of stationery and switchboard cover
8. Preparation of documentation for EU release
9. Validation / documentation store activities including pallet archiving / retrieving for all departments
10. Update SOPs / FORMs, create new systems on a continuous improvement basis
11. Collation of data for preparation of PQRs
12. Document Control; the issuance and reconciliation of controlled documentation
13. Ensure there are no overdue Quality System records that are attributable to your name.
14. Support, as required, activities that relate to client audits and regulatory inspections.
15. Keep abreast of and maintain systems in line with changing regulations and industry expectations.
16. Constructively challenge deficiencies and inefficiencies.
17. Identify and participate in continuous improvement initiatives within Quality.