Computer Systems Validation (CSV) Engineer
- Antwerp
- Contract
- Life Sciences, Commissioning, Qualification and Validation
This vacancy has now expired
Responsibilities:
- Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities
- Develop, implement and execute validation studies for cGMP-critical computerized systems to demonstrate compliance to cGMP, User, and Regulatory requirements
- Perform validation of systems in accordance with cGMP and cGLP’s
- Ensure that the Validated Status of computerized systems is in compliance with cGMP at all times
- Provide technical assistance on current US FDA and EU validation requirements
- Generate validation documentation (protocols/reports) and provide assistance with the execution of protocols for computerized systems
- Responsible for the validation documentation through approval and implementation
- Provide input in review/assessment of changes
- Conduct statistical analysis of validation data & testing results
- Investigate/troubleshoot validation problems
- Develop protocols to ensure quality standards
- Project experience with rolling out software packages
- Carry out Data migration activities and related tests - current procedures adapted and re-written
- Towards the end of the project, carry out training of new application
Background:
- Project management - able to execute projects to plan
- Validation tests
- Data migration
- Writing and adjusting procedures
- Delivering training
- Competent knowledge of Computer Systems Validation
- Full understanding of relevant quality and compliance regulations
- Capable of troubleshooting validation issues associated with projects, e.g. process development
- Pharmaceutical sector experience and GMP environment
- Good knowledge of English and Dutch Language
- Computerized systems / digital tools (e.g. BioLIMS Laboratory Execution System, Electronic flows)
- Agile methodology knowledge
Please apply today for further information!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
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