Our client is a professional Pharmaceutical organization, based in Noord-Brabant Netherlands.
Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.
Work together with production and maintenance team to resolve the quality related problems.
Review and approve class / Non Conformances.
Review and approve batch record exception reports.
Coach production and maintenance staff to improve on quality and to limit number of errors.
Perform finished product checks during (commercial) production runs.
Complete batch release preparation prior to Qualified Person disposition.
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent :
Bachelor's Degree in Life Sciences or related field or the equivalent combination of education and / or experience.
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.
Manufacturing and / or Quality analytical processes and operations.
Fluent in English language.
Systems you have to work with :
TrackWise (NC / CAPA).
MS Office (Word, Excel).
Werum PAS-X (electronic batch records).
Skills : Analytical.
Hands-on and result driven.
Strong communication skills.
Excellent in English