:
1. Review of executed batch records, creation of certificate of packaging
2. Support QA Pre-Approval as required by line manager/workload: Review and quality approval of pre-executed batch documentation, finished product with TOE and label components, change orders, packaging and labelling requests, job specifications, packaging orders, LINKS reports, randomizations, SPA and supporting documentation
3. Liasing with project managers to ensure the above mentioned documents are according to customer and regulatory requirements (including Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines) and Fisher Clinical Services Standard Operating Procedures (SOPs)
4. Coordination and internal communication regarding the scheduling and completion of the documentation reviews and approvals
5. Supply of information internally regarding the documentation review and approval process to support project planning
6. Provide support to improve documentation right first time metrics
7. Ensuring any deviations or quality issues are appropriately documented
8. Inputting or analysing data for quality metrics
9. Inform Supervisor of quality issues
10. Maintain accurate records for all work activities
11. Training and introduction for new team members and for other FCS departments ( CS, CSOS etc.)
12. Organising/executing/documenting GMP document archival (internal/external)
13. Provide support for the larger Quality department which may include tasks such as:
14. Participation in Practical Process Improvement or other projects
15. Review and disposition decisions according to the agreed customer process for transport deviations and temperature excursions
16. Supporting the review and approval of Pharma Unit Trackwise problem reports (PRs)
17. Acting as a customer quality contact, answering client questions with regards to executed batch records
Qualifications:
18. Experience or degree in the pharmaceutical industry, quality control/quality assurance, medication handling, scientific field or equivalent
19. GxP training or experience
20. Demonstrated ability to perform detail-oriented tasks
21. Bachelor’s degree in science or equivalent or GxP training or previous experience in the pharmaceutical industry, quality, medication handling or scientific role
22. Excellent communication and organizational skills
23. High level of accuracy and efficiency
24. Ability to express detail in simple terminology, both written and verbal
25. Command of English and German at professional level