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Release file preparation specialist (m/f/d)

Biberach
GULP – experts united
Inserat online seit: 27 Januar
Beschreibung

For a renowned pharmaceutical company based in Biberach, we are currently looking for a Release File Preparation Specialist (m/f/d) for the Rohrdorf site.

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. As a rule, a permanent 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 compiling the release documentation within the clinical study team
11. You will create the supply chain document, select suitable release scenarios and ensure that all relevant documents are provided on time
12. Your tasks also include the independent technical representation of team-related activities and their scheduling in clinical study teams in compliance with all legal and regulatory framework conditions
13. You will also be responsible for evaluating risks and developing suggestions for improvement
14. In addition, you will work as an SME in various innovation projects and actively contribute ideas for process improvement
15. Last but not least, you will support internal inspections by providing documents and presenting processes from your own area of responsibility

Your profile

16. 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 correspondingly many years of relevant experience
17. Experience in GMP-regulated environments (pharmaceutical development or production)
18. Very good knowledge and confident handling of MS Office applications and SAP-based systems
19. Efficient, independent and meticulous working style
20. Reliability and flexibility as well as strong communication and teamwork skills
21. Proactive and goal-oriented communication skills in German and English

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