Why This Role Stands Out
You will play a crucial role in the final release of investigational medicinal products, contributing directly to groundbreaking pharmaceutical development. This position is ideal for a scientist or pharmacist with strong regulatory knowledge and a passion for quality assurance who thrives in a collaborative environment. Apply now to join a leading company and advance your career in the dynamic pharmaceutical industry.
Quick Overview
Job Description
Specialist Final Release | Biberach an der Riß, Germany | On-site
We're hiring on behalf of a prominent player in the pharmaceutical industry, recognized for its dedication to advancing healthcare and fostering a collaborative work environment. This organization is seeking a driven professional to join their team and contribute to critical release processes.
The Role
- Support the Subject Matter Expert/Qualified Person (QP) for investigational medicinal products.
- Review release documentation for investigational medicinal products.
- Assist with the subsequent certification of investigational medicinal products by the QP.
- Document review results and associated Key Performance Indicators (KPIs).
- Improve and optimize the release process and associated systems.
- Resolve outstanding issues in collaboration with internal and external stakeholders.
- Assign and document batch status, including maintaining batch-related data in CTSS according to current internal instructions.
What You'll Need
- Master's degree in a scientific field or completed vocational training in a pharmaceutical setting.
- Several years of professional experience in pharmaceutical development, manufacturing, packaging, and/or testing.
- Experience in clinical trials or quality assurance environments.
- Strong knowledge of national and international regulatory requirements for investigational medicinal products and clinical trials, as well as current cGMP and quality assurance guidelines.
- Proficient MS Office skills.
- Familiarity with SAP applications is desirable.
- Good written and spoken German and English skills.
- High degree of responsibility, teamwork, and excellent communication skills.
What's On Offer
- Performance-oriented salary package based on qualifications and experience.
- Attractive social benefits, including holiday and Christmas bonuses.
- Contribution to company pension scheme after probation period.
- Up to 30 days of vacation per year.
- Individual training opportunities with reputable partners.
- Discounts at sports, leisure, and wellness facilities.
Apply via Haystack today!
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