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Computer System Validation Expert

Réf.MKO-1022 - 2019/10/08

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criteria

Location :
Switzerland
Business area :
Life Sciences
Job :
Engineering / Technical
Type of Contract :
Permanent
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For 50 years, we've been driven by the firm belief that engineers are the architects of tomorrow's world, leading the way with their daring, their expertise and their ability to push boundaries.
Every day, our 5,700 employees innovate for our clients, partnering the world's greatest engineering projects in the fields of energy, healthcare, life sciences and transport.
A fast-growing international Group, we are present in 14 countries (in Europe, the Middle East, Asia and Africa).

Well known for our expertise in CQV (Commissioning Qualification Validation) and specialists in projects with strict technical and regulatory constraints, we partner pharmaceutical laboratories and high-tech industrial players to manage their capital expenditure and meet the challenges they face in terms of increasing safety and reducing costs and market lead times.
We innovate for our clients and provide them with disruptive technologies in the areas of data integrity, cybersecurity and predictive maintenance.

Job Description

As a consultant, you will support our client in all their industrial projects, on the computer systems & automatized systems validation activities in a GMP regulated environment.

Key responsibilities:

- Determine validation plan for computer systems and automation systems
- Create & review risk analysis
- Monitor quality in all department and ensure compliance with all regulation,
- Participate in the development and implementation of standard template to ensure effective CSV
- Participate in approvals of user and functional requirements for new and existing computer systems subject to validation
- Execute QA reviews and approvals of all validation related documentation (IQ, OQ, PQ, URS and Traceability Matrix)
- Execute and follow up of system testing
- Develop validation protocol and summary report
- Ensure that the project follows relevant quality regulations
- Establish good and close working relationship with project stakeholders and internal customers



Profile

- Experience of min. 5 years in the Biopharmaceutical / Life Sciences industry in GMP environment
- Extensive experience in computer system validation, and in project management for validation activities
- Good knowledge of pharmaceutical regulations: GMP System, GAMP 5, CFR Part 11
- Excellent knowledge of English, with a good level of French or German


At Assystem, everyone holds the reins for their own careers. Our role is to offer you the opportunities and resources you need to reach your full potential.

So why not join us and help shape the engineering landscape of the future?

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