id:
ZmI4MWRiZDctNTM5Yy00Y2U0LTkxY2MtYTIwOGIzM2I5Njk2IDM

reference: fb81dbd7-539c-4ce4-91cc-a208b33b9696

documentId: 58374649

connectionPointId: 3

lastModificationDate: 1537848240750

Functietitel: QA Compliance Officer

Functieomschrijving:
For one of our pharmaceutical clients in the area of Breda, we are looking for a QA Compliance Officer. You will provide QA guidance and support in the production area and  perform batch record review of batches assembled, packaged and labeled on site, and contract manufacturers. You will also establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person In this role your responsibilities will be: 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 case of production queries (quality related) during packaging and labeling 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 labeled at ABR and contract manufacturers in preparation for disposition by QP.  Act as author for operational SOP’s and Work Instructions  Review of operational SOP’s and Work Instructions  Review and approve class I Non Conformances  Initiate and own QA Non Conformances as needed.  Approve Maximo Work Orders  Review and approve test protocols before use in production  Perform GMP compliance checks in production  Assist in development and delivery of GMP training activities for QA and production staff  Participate in QA production related projects as needed  Assist in various investigations as needed  Assist in ABR projects and improvement efforts as needed  Responsible for preparation of weekly/monthly metrics  Own and maintain departmental performance boards 

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2111

abstractJV_contact_0:
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requiredEducationLevelCode: 5

requiredYearsOfExperience: 2

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Werkgever Naam: PAUWELS CONSULTING NV

employer_website: http://www.pauwelsconsulting.com

source: PARTNER