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.