Senior Associate QA Breda • Hays

Vacature in het kort

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Your new company 
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.  The company focusses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, they have grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Your new role 
We are looking for an outgoing, multitasking mediator with strong communication skills and the ability to work under pressure. GMP experience is a plus. The successful candidate will:

• Provide QA guidance and support in the production area at ABR.
• Understand and apply principles, concepts, theories and standards of the technical/scientific field. 
• Establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person.
• Provide daily guidance and support to production staff in regards to compliance with Standard Operating Procedures and Work Instructions.
• Act as a first point of contact in the case of production queries (quality related) during packaging and labelling operations. - Review and approve batch production record data entries before production activities take place.
• Perform finished product checks during (commercial) production runs.
• Compile and review batch records for lots assembled, packaged and labelled at ABR in preparation for disposition by QP.
• Perform GMP compliance checks in production. - Review and approve deviation records. - Initiate and own QA deviations as needed.
• Act as author for operational SOP’s and Work Instructions, as needed.
• Assist in development and delivery of GMP training activities for QA and production staff.
• Participate in QA production-related projects, as needed

• MBO or BSc degree in Pharmaceutical/Life Sciences or related field or the equivalent combination of education and/or experience.
• Typically, 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.
• Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
• Experience with Manufacturing and/or Quality analytical processes and operations.
• Fluent in English language

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