Quality eSystems Consultant
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Hobson Prior are currently working with a world-wide biopharma organisation focused on improving the lives of patients globally through pioneering medicines. Our client is seeking a Quality eSystems Consultant to join them on a contract basis in Switzerland.
- Understanding the Data Integrity methodology in place at the organisation's manufacturing site, Supporting the Principal Specialist QA eSystems for:
- Creating/updating/reviewing data integrity assessments of new and existing systems including, but not limited to, manufacturing and laboratory systems to ensure compliance with regulatory requirements and company established requirements for data integrity.
-Reviewing IT Manufacturing and Validation documentation in relation with the remediation actions defined and/or as part of system updates / enhancements.
- To ensure an effective follow-up of activities on-going.
- Support the Principal Specialist QA eSystems in mitigation and/or remediations when data integrity gaps will be identified.
- Co-operating with and providing support and guidance to other departments and functions for Data Integrity and CSV topics.
- Ability to work independently and proactively on routine tasks.
- Ability to focus and attention to details.
- Customer-focused, results driven and problem-solving skills.
- Good interpersonal, collaborative and organization skills.
- Good knowledge in English, written communication skills.
- BS or MSc in Science, Computer Science or related field.
- A minimum of 3-5 years of experience in a pharmaceutical company or other related industry, ideally in Computerized/Automated System Validation with a first Data Integrity experience.
- Knowledge in Health Authority regulations and guidances related to data integrity and computerized system validation requirements (FDA, PIC/S, GAMP5).
- Previous experience in Data Integrity gap assessment and/or remediation actions plan is preferred.
- French is mandatory.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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