QA engineer lab equipment qualification
Locations: Beerse, Belgium
Functions: Quality (Generalist)
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Requisition ID: 1905757561W
The Janssen Beerse Site Quality Department ensures that all GMP activities of manufacturing, packaging, labelling, testing, release and distribution of investigational and commercial products at/from the Campus Belgium are carried out as required by GMP legislation.
Within this department, the QA Qualification group - section lab equipment - is responsible to ensure compliance of all qualification activities related to lab-equipment within SMPD (Small Molecule Pharmaceutical Development) and JSC (Janssen Supply Chain, more specific for commercial production).
The main responsibilities of the QA Qualification Engineer related to lab equipment qualification consist out of:
* Maintaining the qualification status during assessment and execution of changes and projects.
* Review and approval of qualification documents (master documents, protocols, reports, rationales, SOP's, release notes, etc.)
* You work closely together with the qualification teams for the introduction/retirement of new equipment or changes to existing equipment. You provide advice and support for the preparation of qualification related activities and overview the cGMP aspects in these projects. You are a member of cross-functional teams to realize cross-departmental objectives.
* Guarding the (c)GMP aspects in different qualification projects.
* Review and approval of change controls that require qualification activities.
* Review and approval of discrepancies/events/non-conforming situations occurring during execution of qualification activities.
* Review and approval of qualification related corrective actions (correction, CAPA)
* Maintain a current knowledge of international regulations, guidelines and industry practices related to qualification topics through training, internal and external benchmarking and literature studies.
* Participate in system and process improvement / optimisation projects and assure quality and compliance aspects.
* Participate in the preparations for internal and external inspections.
* Knowledge of methodologies, concepts and requirements related to system validation
* FDA - 21 CFR Part 210, 211 Good Manufacturing Practice for Finished Pharmaceuticals
* FDA - 21 CFR Part 11 Electronic records and electronic signatures
* EudraLex - Volume 4: EU Guidelines to Good Manufacturing Practice
* European and United States Pharmacopoeia and applicable guidelines
Master degree in technical / chemical / pharmaceutical / biomedical area or equivalent through experience.
* Excellent verbal and written communication skills in Dutch and English
* Collaboration and teaming skills
* Focused on solutions
* Strong quality mind-set
* Persuasive and credible to act as subject matter expert during internal and external regulatory inspections
* Influencing and negotiation skills
* Mind-set for innovation and optimization.
* Fluent in Dutch
* Fluent in English
Specific know-how of systems:
* Trackwise (Quality Management Software)
* Docspace (Document Management System)
Janssen Pharmaceutica N.V. (7555)