Kennziffer der Stelle
Operations — Consulting
3 bis 5 Jahre
For one of our clients in the pharmaceutical industry, we are looking for a medior/senior Computer System engineer (CSV).
The CSV role is computer System Validation, focused on quality and computer/automation or technical basic knowledge of the systems.
What will be your tasks?
- Ensure the execution or revision of the required pre-tests before starting the final implementation of the new processes.
- Coordinate all GMP documentation necessary for change control management (VP - TCD - VSR
- QAGMP authorization - QAGMP approval - external contingent documentation, etc.).
- Drafting of URS, FAT, SAT, IQ, OQ, PQ validation protocols and analyzing the results during PQ passages.
- Ensure the planning of validations in partnership with the C&M/QA departments and production
- Ensure communication with the production team.
- Ad hoc assemblies/resources for validation.
- Ensure the operational management of technicians dedicated to validations.
- Ensure all deviations related to the implementation of the change.
- Track QC results for each validation cycle.
- Ensure timely collection/transfer of approved local documents to RA department to ensure timely submission of case.
- Ensure the review of the preparation of the file in partnership with the QA before the submission of the file to the authorities.
Fundamental research • Microsoft Office • Biotechnology • Project management • Engineering • Teamwork • Vp • Tcd • Vsr • Urs • Fat • Pharmaceutical sector • Validation of IT systems • C&m • CAPA • Change control • IOQ • PQ • IQ • Validation • Good Practices (GxP) • Verification and Validation
• Good Manufacturing Practices (GMP) • FDA Good Manufacturing Practices • Gmp
- Degree in engineering or scientific bachelor (bio engineer, electronics, computing, automation, industrial engineer, IT...)
- 1 year experience on pharmaceutical industry or 1 year training
- Good communication skills (close interaction with stakeholders)
- Problem-solving skills
- Motivation to provide result on time
- Determines how to move the project forward
- Analytical thinking, requests and execution, problems, project plan, timelines...
- Interact closely with the stakeholders, coordination
- Good communicator between stakeholders Readiness to demonstrate a proactive attitude
- Good verbal and written communication skills
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