CSV Specialist - Geneva

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To strengthen our Qualification & Validation team, we are recruiting a Computerized System Validation Specialistbased at our headquarters and biotech production site in Geneva. Reporting to the Head of Qualification & Validation, your mission is to is to manage the computerized system validation and data integrity activities.Your Main Responsibilities Are As Follows

• Be the main contact point for Computerized System Validation (CSV) and Data Integrity topics related to equipment and IT systems under your responsibility (laboratory and manufacturing)
• Define and implement qualification strategies, CSV and Data Integrity within projects and for routine
• Realize the periodical review for the systems under your responsibility
• Manage and maintain up to date systems under responsibility (biotech) to ensure Data Integrity compliance, support and define remediation plan for obsolescence
• Ensure the technical support for improvement and investigations, on system under your responsibility, within GMP compliance.
• Ensure inspections/audit preparation and success of them as CSV expert and strategy leader

To carry out this mission, we are looking for a person with the following profile:

• Bachelor or Master’s Degree in Engineering or Computer Science (or similar background)
• At least 4 years of experience in Computerized System Validation within the pharmaceutical industry
• Solid knowledge of pharmaceutical regulation and guidelines
• Ideally, good technical knowledge on iFix, Wonderware, Winprogress and WinCC
• Full fluency in French with good command in English

You are an experienced team player who enjoys working in a fast paced, hands-on and flexible environment. Thanks to your communication and interpersonal skills, you know how to establish collaborative links with different stakeholders. You like to take a step back to analyze situations and propose new strategies. Finally, you define yourself as a solution-oriented and methodical person who drives novelty.If you are looking for a company where you can develop new ideas and leave your footprint, apply as soon as possible and join OM Pharma!About UsOM Pharma is a global Geneva-based biopharmaceutical company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.It operates worldwide through a strong network of international partners and invests its profits in R&D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections.The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances.For more information, visit the website: ompharma.com .