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QA OPS Support - Expert 1 - All Genders at Merck Serono Co., Ltd.

Corsier-sur-Vevey, Vaud, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

28 Dec, 25

Salary

0.0

Posted On

29 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Good Manufacturing Practices, Good Distribution Practices, Biotechnology Processes, Analytical Skills, Investigation Tools, Pharmaceutical Systems, Computerized Systems, Trackwise, SAP, French Proficiency, English Proficiency

Industry

Pharmaceutical Manufacturing

Description

Romain Vecchini Clelia Liberatore HC-GM-QFQBY Quality Operations Support Corsier-sur-Vevey | Route de Fenil Z.I.B. Your Role As a member of the QA Operations Technical/Support team for the Warehouse, Equipment & Maintenance (E&M), Dispensing, Data & Digital departments, you will support activities linked to Quality Assurance for these departments. You Will Be Responsible For: Acting as the QA point of contact for deviations, Critical Control Points (CCP), and Corrective and Preventive Actions (CAPA). Participating in QA on-the-floor activities to ensure compliance with regulations related to these departments. Reviewing, approving, and following up on current Good Manufacturing Practice (cGMP) documentation. Participating in health authority inspections and audits. Your Profile Degree in Pharmacy, Engineering, or an equivalent field of study. At least 5 years of experience in the pharmaceutical or biopharmaceutical industry in GMP manufacturing. Excellent knowledge of Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP). Good knowledge of biotechnology processes. Strong analytical skills and experience with investigation tools (e.g., 6M, 5 Whys). Proficient knowledge of pharmaceutical and computerized systems (e.g., Trackwise and SAP). Excellent proficiency in both French and English.

Responsibilities

You will act as the QA point of contact for deviations, Critical Control Points (CCP), and Corrective and Preventive Actions (CAPA). Additionally, you will participate in QA on-the-floor activities to ensure compliance with regulations related to the Warehouse, Equipment & Maintenance, Dispensing, Data & Digital departments.