We are currently looking for a Release File Preparation Specialist (m/f/d) on behalf of our business partner from the pharmaceutical industry in Biberach .
Here's what we offer
1. Attractive salary and long-term job security through group affiliation
2. Up to 30 days vacation per year
3. Contribution to company pension scheme after end of probationary period
4. Extensive social benefits, including Christmas and vacation bonuses
5. Reimbursement of travel expenses
6. Generally an open-ended employment contract
7. Good chances of being taken on by our business partners
8. Tailored further training opportunities and free language courses
9. A wide range of employee benefits
Your tasks
10. In your new role, you will be responsible for independently compiling the release documentation within the clinical study team.
11. You will also be responsible for representing and independently representing the Clinical Trial Manufacturing/ Release File Preparation (CTM RFP) activities and their timelines in the clinical study teams in compliance with legal and regulatory requirements.
12. You will also be responsible for evaluating risks and developing suggestions for improvement.
13. As a Subject Matter Expert, you will work on various improvement and innovation projects.
14. You will also support internal inspections by providing documents and presenting processes from your own area of responsibility.
Your profile
15. Completed scientific master's degree or bachelor's degree with several years of relevant professional experience, preferably in the pharmaceutical industry, alternatively a completed scientific education with additional training as a master craftsman or technician and several years of professional experience
16. Experience in GMP-regulated environments in pharmaceutical development
17. Very good knowledge and confident handling of MS Office applications and SAP-based systems
18. Efficient, independent and meticulous working style
19. Reliability and flexibility as well as strong communication and teamwork skills
20. Proactive and goal-oriented communication skills in German and English