QA Engineering Expert

vor 2 Monaten

Aubonne VD, Waadt, Schweiz Randstad Vollzeit

For our client Merck based in Aubonne, we are looking for a QA Engineering Expert for a duration of 9 months (until

Your role:

Ensure that equipment & automated systems implemented are in accordance with internal procedures and current guidelines/regulations (including procedures related to change, risk and deviation management)Support Equipment and Automated Systems deviation management.Support, review and approve change control proposal (CCP) as QA engineering for projectsParticipate to risk assessmentsReview and approve quality documents (design documents, validation plans & summary reports, procedures, protocols, data reviews, reports and procedural documents)Ensure that validation, calibration and preventive maintenance programs are in place and are respected Routine activities: Review and approve quality documents (operational documents, procedures, forms, intervention report for automation activities) for equipment and automated systems activitiesEnsure support for deviations related to equipment and automated systems including QA assessment, investigation and CAPA review / approval and closureEnsure that periodical technical interventions programs are in place and respected.Participate to annual reviews as required.Ensure QA activities in SAP-PM system: equipment/system and maintenance plans creation /modification/removalSupport department to guarantee that equipment and automated systems procedures and forms are understandable and easy to complete and review.Participate to seminars and training sessions on equipment and automated systems qualifications best practices to maintain "state-of-the-art" in-house expertise.Ensure backup of the QA engineer for project and routine activities
qualifications Your profile: English B2 or aboveMaster / Bac +5 levelKnowledge of equipments and automated systemsKnowledge on Trackwise, CSV and SAP are mandatory3-5 years of experience in a similar positionExperience in Quality AssuranceExpertise in cGMP best practices

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