Real Staffing is a global leader in the provision of pharma, biotech and medical devices recruitment services.
Working across Europe, the US and Asia Pac we are one of the world's most extensive pharma, biotech and medical devices recruiters and have one of the largest networks of specialist recruiters globally.Our client, one of the world's leaders in the pharmaceutical sector, is currently looking for a Lab Equipment Qualification Engineer.
About the position:
The main responsibilities 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, etc.)
- 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 (CAPA)
- Maintain a current knowledge of international regulations, guidelines and industry practices related to qualification.
- Participate in system and process improvement / optimisation projects and assure quality and compliance aspects.
- Participate in the preparations for internal and external inspections.
- You have knowledge of methodologies, concepts and requirements related to system validation, such as:
- 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
- You have a Master degree in technical / chemical / pharmaceutical / biomedical area or equivalent through experience.
- You have excellent verbal and written communication skills.
- You have Collaboration and teaming skills.
- You are focused on solutions and have a strong quality mind-set.
- You are persuasive and credible to act as subject matter expert during internal and external regulatory inspections.
- You have good influencing and negotiation skills.
- You have a mind-set for innovation and optimization.
- You are fluent in both Dutch and English.
- You have already worked with Trackwise, Docspace and SAP.