QC specialist – Method Transfer
Main Responsibilities
1. Planning and execution of a methodtransfer
2. Responsible foranalytical investigations and problem-solving activities
3. Writing of analytical documents linked to the method transfer.
4. Responsible of Validation / qualification of analytical equipment.
5. Training of personnel for execution and review, review of data, and completion of documentation.
6. Complete review/approval of validation documentation for other team members on request
Compliance
7. System documentation, including SOPs, protocols, Validation lifecycle/CSV documentation.
8. Ownership of quality systems actions (IR's, CAPA, CC) ensuring timely closure and performance trending.
9. Participation in internal and external audits and active follow up on audit items
10. Identifying productivity and compliance opportunities and driving same to completion.
Qualifications and experience
11. Minimum 2 years experience in the pharmaceutical/ medical device industry.
12. Degree (or equivalent) in Chemistry / Microbiology, or in a Science/Engineering subject.
13. Experience in Method transfers.
14. Experience in Validation / qualification of analytical equipment
15. Familiar with QC systems and processes, especially LIMS, MODA & Veeva.
16. Experienced in data compilation, review and report generation
17. Experienced in Data Integrity requirements for QC.
18. Project Management - leading & oversight as well as contributory role.
Skills required:
19. Highly attentive to detail
20. Self-motivated, goal driven person
21. Experienced in technical problem solving
22. Good organisational skills
23. Strong ability to perform, challenge and positively influence in an interactive team environment.