Are you a Compliance Clerk and already have some experience in quality control? Are you looking for a new and varied role in which not only your specialist knowledge but also your ability to work in a team and motivation are valued? Then our team of experts at Randstad professional solutions has the right position for you: We are currently looking for an Employee Quality & Compliance at the Penzberg site on behalf of our business partner in the pharmaceutical industry. Apply today and start your new job tomorrow! We do not exclude anyone, but welcome every application.
Here's what we offer
1. Attractive salary package with Christmas and vacation bonuses
2. Reimbursement of travel expenses
3. Up to 30 days vacation per year
4. Further training through e.Learning offers
5. Open corporate culture
Your tasks
6. Supporting the Group Manager and other managers on issues relating to Quality & Compliance
7. Preparation of the internal batch record review in consultation with the responsible product group manager
8. Preparation of the risk-based evaluation of the batches produced and coordination of the root cause analysis and action tracking in the event of deviations with the involvement of all relevant interface partners
9. Maintaining the internal release system (SAP-based) for the digital storage of all batches produced
10. Independent creation of deviation reports in collaboration with the relevant interface partners
11. Coordination, processing and updating of internal manufacturing regulations in collaboration with all relevant interface partners
12. Creation of SOPs and specification documents
13. If necessary, training employees in compliance with the applicable quality management system
14. Ensuring the correct filing/archiving of records and documents in accordance with the currently valid specifications
15. Independently creating and maintaining change requests (equipment) in the area and independently coordinating all necessary actions in accordance with the applicable specifications
16. Accompanying tours of the production areas
17. Checking hygiene measures (hygiene plans) and following up on actions resulting from monitoring limits being exceeded
Your profile
18. Degree in natural sciences (preferably a Master's degree in chemistry)
19. Ideally professional experience in the pharmaceutical or chemical industry
20. Experience in or understanding of production and quality control processes and general business practices within the regulated diagnostic/pharmaceutical industry
21. Knowledge of the relevant DIN ISO standards (13485, 9001) and other relevant regulations (e.g. GMP, IVDD, FDA QSReg)
22. Experience in process analysis, qualification and validation
23. Fluent German and good written and spoken English skills