Description
QC Specialist (m/f)
Reference: -en
Start: ASAP
Duration: 12 MM++
Main tasks:
- Subject Matter Expert in Quality Control and stability related topics, Investigations and issues
- Responsible for the maintenance and revision of specifications and Methods for products manufactured at CMOs including assessment and Implementation of new regulatory requirements
- Information of quality site management for implementation at the CMOs
- Support change control for Specifications, Analytical methods, Stability Protocols and other laboratory impacting activities
- Support the Local and Global Change Commission regarding changes in Analytics and Methods Impacting a CMO
- Provide quality oversight of QC related activities performed at CMOs
- Review and assess QC activities at CMOs against cGMPs, regulatory Dossiers, Quality Requirements and Global Standards and Practices
- Review CMO stability protocols and reports
- Support of analytical transfer activities (e.g. support in providing documents, Samples, reference standards)
- Contribution to the elaboration of quotes/purchase orders for analytical Activities
- Analytical support for regulatory submissions and HA requests in Collaboration with the product quality team
Main qualifications
- M.S. in Science or equivalent, Graduate degree preferred
- Profound experience in Quality Control or Analytical Development including Laboratory experience (activities or supervision)
- Strong knowledge of global pharmaceutical industry regulations, standards and guidance documents
- Ability to communicate clearly and professionally both in writing and verbally
- Flexibility in work hours and travel (up to 20%) to meet business objectives
- Ability to speak English and another European language such as German, French or Italian preferred
Main advantages:
- A very renowned company
- You will work in an international environment
About us:
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.
My contact at Hays:
My contact person:
Andrea Beck
Referencenumber:
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