QA Associate QMS (m/f/d)
Responsibilities
- Receives incoming documents e.g. executed batch records, work orders, vendor labels, packaging instructions etc.
- Performs documentation in respective tools. Prepares documentation needed for the batch record review e.g. Analysis Reports, Specifications for clinical development, country label approval etc.
- Support the timely release of GMP batches of labels, primary packed materials and Investigational Medical Products
- Review and approve GMP relevant documents, e.g. work orders, packaging master documents, clinical study labels, Batch record review for both packed material from internal or contractors. Compiles, Notifications of Extension to be issued due to revised expiry dates. GMP relevant documents in own area of responsibility e.g. CoC's, BRR Checklists
- Scan, file and archive documents owned by QA e.g. Certificate of Compliance, Batch Record Review Checklists
- Write and review procedures and forms related to the QA Batch record Review Process
- Contributes to Right First Time performance reports for release of IMPs
- Supports and collaborates with QA & GCS Line Unit in process improvements, Quality & Compliance issues and in the use of GMP relevant IT tools and processes
- Support the use, improvement, evaluation and implementation of GMP relevant IT tools and processes
Profile
- Apprenticeship or Bachelor's Degree in relevant field
- Profound German knowledge
- English knowledge
- Communication skills to sufficiently address GMP and logistic related questions with line unit experts
- Scientific, technical and regulatory knowledge in a specific area
- Basic knowledge of drug development
- Detailed knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines
- Profound organizational skills
Benefits
- Interational Environment
- Very renowned Pharmaceutical Company
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in 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 experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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