We are currently seeking a Senior Compliance Specialist (m/f/d) on behalf of our business partner in the pharmaceutical industry, located in Biberach .
Here's what we offer
1. Attractive salary and long-term job security through affiliation with a large corporation.
2. Up to 30 days of vacation per year
3. Company pension scheme contribution after the end of the probationary period
4. Extensive social benefits, including Christmas and holiday pay
5. Reimbursement of travel expenses
6. Usually an open-ended employment contract
7. Good opportunities for acquisition with our business partners
8. Tailored professional development opportunities and free language courses
9. A wide range of employee benefits
Your tasks
10. In your new role, you will handle various aspects of the GMP process related to the qualification of disposables/packaging materials.
11. As part of the Change Control process / Lifecycle Management, you will process complex, cross-departmental change requests and ensure their timely implementation.
12. Taking into account regulatory requirements as well as internal and external needs, you will create and revise GMP documents such as specifications and SOPs.
13. They undertake diverse interface activities, including those across multiple locations, in collaboration with supply chain management, quality assurance, and production.
14. We appreciate your expertise not only in handling deviations, investigations and CAPAs, but also in supporting the preparation of audits and inspections.
15. They handle periodic reviews of disposables and packaging materials as part of lifecycle management.
16. They create binding statements on behalf of clients regarding material-specific properties.
Your profile
17. Completed diploma or master's degree in pharmacy, chemistry, biotechnology or comparable field with several years of professional experience
18. Expertise in pharmaceutical quality control as well as the assessment, monitoring and implementation of GMP requirements.
19. Knowledge of the regulatory requirements for disposables and packaging materials
20. Knowledge of QM systems such as SAP, Trackwise and Veeva Vault
21. Good written and spoken English skills
22. Good MS Office skills
23. Presentation and moderation skills as well as assertiveness for goal- and deadline-oriented conclusion of quality events.
24. Personally, you are distinguished by your strong communication skills as well as your planning and organizational skills.