Ort: Switzerland - Meyrin/Geneva
Firma: OM Pharma
In view of our continued global growth, we are looking for further support and recruiting a Computerized System Validation Coordinator & Automation Manager at our biotech production site in Geneva. Reporting to the Head of Computerized Systems and Qualification, your mission 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 (laboratory and manufacturing) and IT systems
- Coordinate CSV teams (internal and external) for projects and routine
- Define and implement qualification strategies, CSV and Data Integrity within projects and for routine
- Act as a validation specialist for the given equipment / systems
- Create and manage CSV documentation
- Establish and/or update equipment or systems SOPs
- Ensure the technical support for improvement and investigations, on systems under responsibility, within GMP compliance
To carry out this mission, we are looking for a person with the following profile:
- Bachelor or Master Degree in Computer Science (or related field) or Engineering
- Experience in CS validation within the pharmaceutical industry
- Very good knowledge of pharmaceutical regulation and guidelines
- Ideally, good technical knowledge on iFix, Wonderware, Winprogress and WinCC
- Very good interpersonal and communication skills
- Full fluency in French with very good command in English, both in oral and written conversation
You are a rigorous person and autonomous in your work. Endowed with an entrepreneurial spirit, you know how to manage different cross functional stakeholders. You like to take a step back to analyze situations and propose new strategies You define yourself as a solution-oriented and methodical person who drives novelty. Thanks to your communication skills, entrepreneurship and strong team spirit, you integrate quickly into a new environment and easily establish collaborative links with other departments.
If you are looking for a company where you can develop new ideas and leave your footprint, join OM Pharma!
OM Pharma is a global Geneva-based Biotech 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 continues to invest into R&D to develop microbial derived immunotherapeutic products addressing acute and chronic immunological disorders resulting from infections and inflammation. OM Pharma is operating to highest Good Manufacturing Practice (GMP) standards which rely on a high level of Biotech competencies and experienced teams.
The company strives to help patients around the world to live better lives by allowing access to a better management of infectious diseases and immunological imbalances.
For more information, please visit: ompharma.com.