Periode: 1 year, possible extension to permanent
Our client is a consultancy in the food and pharmaceutical industry. They participate in very attractive projects for experienced engineers in the pharmaceutical industry. They offer challenging, varied projects with ample opportunities for personal contributions and development.
Our client is looking for an experienced CSV Consultant that can support and consult at costumers in the pharmaceutical and biotechnology industries. Solving and coordinating problems and solutions focused on computer systems, data integrity and IT compliance will be your main task. The challenge is to dig deep at the client to spot the gaps at the client and to convince the costumer to take care of those gaps according to your advices.
Further related responsibilities:
- Responsible for the the Qualification Plan, Requirement Specifications, User Acceptance test protocol and Qualification Report will be part of your work.
- You are responsible for compliance with the client's requirements and the validated state.
- Responsible for Data Integrity related topics.
- Interpretation of the compliance will be agreed with the Quality Officer.
- Reporting progress deviations to the project leaders.
- (Co-)development of the validation strategy for the validation of an existing production plant and a number of improvements / modifications to the various software applications.
- Responsible for documents, such as validation master plan, risk analyzes, summary reports, requirements specifications.
- Closely follows the progress of the project and reports the status to the project management and management.
- Experience in working according to specific guidelines and rules (eg GMP, GLP, GAMP).
- User experience in software applications in a GMP environment (such as document management systems, MES, ERP, LIMS, BMS, EBR, data history, etc.).
- A broad general ICT / automation knowledge (eg data exchange, data security, infrastructure, PLC, SCADA, MES systems, etc.).
- Familiar with work according to GAMP5.
- Experienced with Data Integrity projects.
- Aware of the current insights regarding 21 CFR-Part11.
- Communicate in English fluently, Dutch much prefered.