QA GMP Roles, Biosimilar R&D and Production

QA GMP Manager, Biosimilar R&D and Production

Due to huge investment and growth my client is looking to expand the QA GMP team on their biosimilars development and production site. This site is going to be keym in the future of the industry and guarantees, personal growth and stability.

They have a full time positions ranging across the seniorities for professionals with QA GMP experience in biotech and biosimilars. Your experience will determine the level of role but generally you will have a broad role in GMP compliance. You do need to speak fluent German and English for this position.

Main Duties Include:

* Ensures adequate quality and compliance of pharmaceutical products manufactured/supplied by respective contract manufacturers by elaborating and executing appropriate monitoring systems
* Escalates Quality / GMP issues and deficiencies to Head Global QA
* Ensures GMP-compliant performance of release testing
* Provides scientific support for production, registration and marketing departments
* Participates in GMP working groups as appropriate
* Approves GMP relevant documents (i.e. product specifications, testing monographs, SOPs, APQRs, etc.)
* Serves as competent counterpart for production, registration and marketing departments (i.e. providing expert opinions / verdicts)
* Performs and participates in audits (authorities, customers, safety, internal, suppliers) as appropriate
* Ensures management training on and awareness of quality and compliance requirements and systems

If this role is of interest to you then do not hesitate to get in contact today as my client is looking to select suitable CV's in the next week. Please send your CV in MS Word format (I am unable to accept PDF copies!) to me directly, Andrew Dixon, at qa@nonstop-pharma.com, or by calling me on +44 207 940 2105 for a discussion in confidence.

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