- Ensure that equipment &automated systems implemented are in accordance with internalprocedures and current guidelines/regulations (including proceduresrelated to change, risk and deviationmanagement)
- Support Equipment and AutomatedSystems deviation management.
- Support, reviewand approve change control proposal (CCP) as QA engineering forprojects
- Participate to riskassessments
- Review and approve qualitydocuments (design documents, validation plans & summaryreports, procedures, protocols, data reviews, reports andprocedural documents)
- Ensure that validation,calibration and preventive maintenance programs are in place andare respected
- Review and approve qualitydocuments (operational documents, procedures, forms, interventionreport for automation activities) for equipment and automatedsystems activities
- Ensure support fordeviations related to equipment and automated systems including QAassessment, investigation and CAPA review / approval andclosure
- Ensure that periodical technicalinterventions programs are in place andrespected.
- Participate to annual reviews asrequired.
- Ensure QA activities in SAP-PMsystem: equipment/system and maintenance plans creation/modification/removal
- Support department toguarantee that equipment and automated systems procedures and formsare understandable and easy to complete andreview.
- Participate to seminars and trainingsessions on equipment and automated systems qualifications bestpractices to maintain "state-of-the-art" in-houseexpertise.
- Ensure backup of the QA engineer forproject and routine activities
- English B2 orabove
- Master / Bac +5level
- Knowledge of equipments and automatedsystems
- Knowledge on Trackwise, CSV and SAP aremandatory
- 3-5 years of experience in a similarposition
- Experience in QualityAssurance
- Expertise in cGMP bestpractices
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QA Engineering Expert - Aubonne, Schweiz - Randstad
Beschreibung
JobdescriptionFor our client Merck based in Aubonne, we are lookingfor a QA Engineering Expert for a duration of 9 months (until
Yourrole:
Routineactivities:
Yourprofile:
