Senior Specialist Final Release (m/f/d)
Your responsibilities
- In you new role, you provide procedural and administrative support for Qualified Persons (QP).
- You review release documentation for IMPs (Investigational Medicinal Products) to ensure compliance to CTAA, cGMP and internal procedures in order to support the subsequent QP release.
- An adequate documentation of review results and KPIs in the release file is also part of your responsibilities.
- You contribute to continuous improvement and optimization of processes and systems related to IMP release.
- Thanks to your communication skills, you effectively interact with internal and external interfaces to resolve open topics.
- You are responsible for the assignment and documentation of batch status as well as entering of batch related data in CTSS in accordance with internal procedures.
Your profile
- Bachelor/Master degree in science and/or professional experience in pharmaceutical development (manufacturing or analytical testing) or quality management.
- Knowledge of national and international regulatory requirements regarding Investigational Medicinal Products (IMPs) and clinical trials.
- Knowledge of cGMP and Quality Assurance requirements.
- High sense of responsibility and ability to work in teams.
- Demonstrated ability to manage complex topics and to work efficient and diligent.
- Excellent communication skills in local and international teams.
- Excellent PC skills (MS Office), knowledge in SAP applications desirable.
- Good knowledge of English language (speak/write)
Your benefits
- Working in an international company
About Hays
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
Staffing process for a permanent or temporary position
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We will review your application documents and carry out a detailed analysis of your professional qualification.
Your contact at Hays
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