Description
For my Client, a global leader in Pharmaceutical Industry,i am looking for specialist to be working temporarily on a Drug Delivery Device Project in the Quality Departement.Please find more informations below:
Drug Delivery Systems Quality Manager
- Duration: to
- Location: Bern, Switzerland
Responsibilities:
- Ensure design control compliance
- Lead the qualification and monitoring of suppliers
- Identify applicable quality and regulatory requirements
- Review and approve all project deliverable (internal and from suppliers)
- Review and approve training, promotional and labelling material - Participate to design reviews
- Participate to material consolidation for submission purpose
- Support regulatory submissions worldwide 510k, CE Marking
- Ensure compliance of design control and maintenance processes to applicable regulations/standards and the company global policies and standards
- Ensure products are developed and maintained according to state of the art practices to reach ultimate product quality
- Participate to material consolidation supporting regulatory submission files to ensure timely approval of combination products worldwide, especially in the US
Requirements:
- Combination products (drug delivery or injectable device)
- Molding knowledge
- Supplier management
- English
- 21CFR4
- CE marking
- Design control process
- ISOCFR820
- ISO14971
- Medical Device Directive 93/42
If you think that you can fulfil the requirements above and if you are keen to discuss the general job market situation in Switzerland, please do not hesitate to get in contact with me.
Best Regards
Sabina Keel
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