Part-time 50% QA Manager - deputy FvP Biopharma

12 months contract - Swiss Market release - region Zurich

Support the QA team of a successful global player with innovative products in most attractive indications. In the role of QA Manager you will setup and maintain the Quality Management System, make sure all processes are in place and assure inspection readiness.

You are part of the Swiss affiliate and collaborate closely with the European Quality Organization.

Your resonsibilities:

• direct technical supervision of all operations
• ensure that all products are handled appropriately and in accordance with any applicable Swiss law and regulation
• ensure that any pharmaceutical products released onto the Swiss market meet the approved specifications and are produced in accordance with Good Manufacturing Practice (GMP)
• support compliance of market Third Party Distribution partners to internal Quality requirements related to distribution and transportation
• ensure that products are distributed to GDP guidelines
• coordinate and promptly perform any recall operations
• decide on the final disposition of returned, rejected, recalled or falsified products
• deal effectively with relevant customer complaints
• approve any subcontracted activities which may impact on GDP
• oversee self-inspections plans and performances
• decide whether or not a batch can be released to the Swiss market
• assess the PQR periodic quality reviews for all products approved for the Swiss market

Your profile:

• B.Sc, M.Sc, PhD in Life Sciences
• 2-5 years of experience in Pharma QMS
• knowledge of GMP documentation requirements and batch release process
• German language skills B2 level upwards

Strong interpersonal communication and collaborative skills in dealing with internal and external stake holders. Act as a quality influencer throughout all steps in the network and show your talent in building trustful and effective relationships.

__Interested? We are looking forward to get in touch with you.
Online application__