Csv Engineer

Belgium  ‐ Onsite
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Keywords

Description

A multinational pharmaceutical organisation based in Belgium currently requires a CSV engineer to join their team. You will be part of the Project Quality Affairs team, where you will ensure daily follow-ups and support of Computer System Validation of the process control systems for a new facility (essentially a DCS system and a limited number of PLC`s).

Responsibilities:
From a quality and validation perspective, contribute to the setup of the lifecycle approach to the entire project (URS, FRS). Review and approval of quality and validation relevant documents, including:

- Validation Master Plan
- FRS, DDS, HDS
- Design review, quality gates, commissioning tests
- Test Procedures
- Validation Protocols and reports
- Documentation packages
- Follow-up of system changes, based on the change control system
- Follow-up of deviation handling and CAPA management
- Proactively detecting and solving non-compliance issues.

Experience:

- You have good knowledge of GAMP5 requirements
- You have some years` experience validating, maintaining or improving process control systems, preferably DCS systems. Experience with Emerson DeltaV would be seen as a plus.
- You have some years` experience in a quality-related function in the pharmaceutical industry. Project experience would be seen as a plus.
- You are familiar with current FDA and European cGMP regulations, with industry standards and regulatory expectations.
- You communicate fluently in English (and ideally Dutch) and have excellent communication skills, both in writing and in speaking.

This is an excellent opportunity to join a global pharmaceutical organisation and is a position not to be missed! Please apply now if you are self-motivated individual who strives for excellence and is able to work well within a team.
Start date
n.a
From
Quanta Consultancy Services
Published at
17.09.2012
Contact person:
Lee Mitchell
Project ID:
421548
Contract type
Freelance
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