QA Officer External Quality

Client

Our client is a consultancy company in the food and pharmaceutical industry.

Middle to Higher education (MBO++-HBO).
A minimum of 8 years working in an FDA or similar regulated environment; Quality Assurance experience preferred.
A minimum of 5 years experience working with pharmaceutical GMPs, specifically biopharmaceutical experience is preferred (QA and/or production).
Able to build connections with stakeholders, and manage across cultures.
Strong interpersonal and written/oral communication skills.
Proficient in applying process excellence tools and methodologies.
Willingness to travel (25%).
English mandatory, other languages are a benefit.

Responsible for providing support to the Quality Department through review of batch and validation documentation, completion of release packages, and management of routine issues.
Ensure the highest levels of quality and compliance for the products products.
Interact with Internal Quality Assurance Managers and External Manufactures to perform batch record review and complete release packages for global markets.
Evaluate batch manufacturing records, deviations, and associated CAPA plans and identify issues which may impact the quality of the product or the compliance to marketing authorizations.
Independently resolve minor issues.
Consult with the account manager as needed for resolution of major issues.
Ensure that all relevant QA related concerns at external manufacturing sites are raised to management.
Extensive (> 3 y) knowledge of GMP, specifically parenteral experience is preferred (QA and/or production).