QC-Specialist (m/f)

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Beschreibung



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
  • Responsible for the 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 for Roche products
  • Review and assesses QC activities at CMOs against cGMPs, regulatory dossiers, Quality Requirements and Global Standards and Practices
  • Review CMO stability protocols and reports
  • Support analytical transfer activities (e.g. support in providing documents, samples, reference standards)
  • Contribute to the elaboration of quotes/purchase orders for analytical activities
  • Provide analytical support for regulatory submissions and HA requests in collaboration with the product quality team


Main qualifications
  • 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
  • Experience in working with multifunctional, multicultural, and global teams
  • Ability to speak English and another European language such as German, French or Italian preferred


Main advantages:
  • Reputable company



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:
Yves Fabien Deschamps

Referencenumber:


Make contact:
Email:
Start
ab sofort
Dauer
12 MM+
(Verlängerung möglich)
Von
Hays AG
Eingestellt
15.02.2019
Ansprechpartner:
Kerstin Werner
Projekt-ID:
1720206
Vertragsart
Freiberuflich
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