QA Engineering Expert
job details
For our client Merck based in Aubonne, we are looking for a QA Engineering Expert for a duration of 9 months (until 31.12.2024).
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 projects
- Participate to risk assessments
- Review 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 activities
- Ensure support for deviations related to equipment and automated systems including QA assessment, investigation and CAPA review / approval and closure
- Ensure 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/removal
- Support 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
For our client Merck based in Aubonne, we are looking for a QA Engineering Expert for a duration of 9 months (until 31.12.2024).
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 projects
- Participate to risk assessments
- Review 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 activities
- Ensure support for deviations related to equipment and automated systems including QA assessment, investigation and CAPA review / approval and closure
- Ensure 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/removal
- Support 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 above
- Master / Bac +5 level
- Knowledge of equipments and automated systems
- Knowledge on Trackwise, CSV and SAP are mandatory
- 3-5 years of experience in a similar position
- Experience in Quality Assurance
- Expertise in cGMP best practices
À propos de l'entreprise
