Description
Are you a CSV Engineer interested in working for one of the leading names in High-Tech Pharmaceutical Engineering? Are you looking for something new?!
Then stop what you are doing and read on!
Title: CSV Engineer
Rate: Negotiable
Location: Groningen, The Netherlands
Positions Available: 1 Engineer
Type: Contract (6-Months)
A Fantastic new role has just opened up at one of our leading Dutch based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.
The proposed start date is ASAP - We need YOU
Responsibilities include:
- The QCSV will provide quality oversight for the implementation/validation efforts, with input from project team, of any GxP computer systems
- Provides regulatory guidance and best industry practices in support of quality management system, risk-based approach and computer system validation.
- Provides IT Compliance solutions and strategic guidance to project team and other stakeholders.
- Provide quality oversight for the implementation/validation efforts, with input from project team, of any GxP computer systems
- Review and approve validation deliverables as required; including validation plans, requirement specification documents, validation protocols, test scripts, validation reports and trace matrices
- Ensure that the control of GxP computer systems is integrated into Quality Management System
- Draft Compliance Assessments/Plans, and Compliance Summary Reports
- Review and approve validation deliverables as required; including validation plans, requirement specification documents, validation protocols, test scripts, validation reports and trace matrices
Requirements:
- 5+ years of relevant experience in the Life Sciences Industry.
- Bachelors' degree in the life sciences/IT field.
- Essential: Extensive background in Lifesciences enterprise IT Compliance, Infrastructure Qualification and CSV.
- Knowledge of Manufacturing and Laboratory Equipment validation and/or Enterprise systems validation
If you are interested by this role then get in touch with me!
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