Experis AG
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Experis AG , Zurich
6 d
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Experis AG , Zurich
1 w
CSV Engineer
Experis is a leading global provider of personalized recruitment solutions and professionals in the IT sector.
On behalf of one of our clients, who's in the pharmaceutical industry, we're looking for a CSV Engineer
Location: Bern
Work Model: Hybrid / 3 days on site reqired
Workload: 100%
Seniority: Expert
Contract: 5 months / possible extension
Requirements
In charge of Computer System Validation (CSV) activities for Technical Services department in order to ensure that:
- Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
- Validation Master plans are up to date and established for all ongoing projects
Essential duties
- Assess and produce the CSV package(s) on an assigned project. Taking accountability for the work to be produced. § Hands on: Plan, coordinate and execute all phases for computer system validation of production and QC Lab systems including but not limited to, Validation plans, FMEA, RTM, DQ, IQ, OQ, PQ test scripts. § Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
- Understand customer needs and define electronic records requirements for computerized system adhering to regulation and company standards
- Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems
- Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups
- Contribute to ensure that changes introduced in the organization of systems, procedures, processes and formulas are managed so that all aspects of the equipment / computerized systems commissioning, and qualification process are assessed and resolved.
Due to Swiss work permit restrictions, we can only consider applications from Swiss citizens, EU citizens, or those with a current work permit for Switzerland.
If you're interested, please feel free to contact me or quickly apply through the system.