Beschreibung
For our pharma client in Basel we are currently looking for a
Computer Systems Validation Specialist (CSV)
Background: Process analytical technologies (PAT) are used to monitor the quality attributes of the product during processing in Real Time. In R&D PAT provides better process understanding through monitoring during drug product and drug substance development. PAT can also contribute to a more reliable scale up and for some products PAT is needed for reliable process control.
The PAT project is an integrated part of our effort to speed up development and production of drug products. The core system is used for processing, reporting, and storage of PAT data from different PAT systems with probes.
Tasks & Responsibilities:
- Computerized system validation of stand-alone systems according to our clients requirements
- Authoring of the system dedicated SOPs and other CSV documentation
- Communication with stakeholders across the organization
- Collaboration with the project team
- Report to the CSV Lead
Must Haves:
- +8 years of experience as CSV Specialist (requirements below included)
- Experience with validation of lab systems in a GMP environment
- More than 4 years of experience in regulated environments
- Project management experience
- Experience in cooperation with lab and service technicians
- Experience in operating different Lab IT systems
- Strong communication skills (very important for this Senior role)
- Fluent in German and English (both mandatory)
Nice to Haves:
+++ Experience with validation of PAT systems is a plus
++ Experience in Pharma is a plus
+ Experience with HP ALM Software is a plus
Start date: 20.05.2019
End date: 31.12.2019 with possible extension
Location: Basel
Are you interested to work in this challenging position? Benjamin Wenk, Talent Acquisition Consultant, is looking forward to receiving your complete profile. Please send an e-mail (see below)
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