Overall external CMO quality activities for Xellia pharmaceuticals
To provide support for internal quality audit at various global manufacturing sites.
Develop Quality Agreements
Manage due diligence audits and provide QA expertise for business development initiatives as required.
Managing various contract manufacturing organization, External laboratories and third party vendors/suppliers.
To plan and conduct vendor audits & external CMO site compliance audits.
Ensure overall GMP and Compliance activities from the product development life cycle processes and commercial manufacturing.
Co-ordination with R&D and Product Supply and provide Quality support in Tech transfer activit...
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