1 Operational risk jobs in Saint-Prex found

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

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