Description
CSV -Technical WriterPeriod: to
Location: Basel
RESPONSIBILITIES:
* Manage, co-ordinate, develop and execute the validation deliverables for a new IS project.
* Support and co-ordinate the qualification and validation processes.
* Support activities include, but are not limited to; the preparation of Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ, OQ/PQ), Data Migration, SOPs and Change controls.
* Facilitate the release of the regulated system for GxP production use in line with project timelines. Support the resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.) Participate in required project teams
* Will be responsible for defining test strategy, designing and developing test cases from software requirements, architecture designs, and code of complex software systems.
* Conduct validation training with project team communicating deliverables, procedures and methods
QUALIFICATIONS / REQUIRED EXPERIENCE
* Bachelor's degree in Automation Engineering, Electrical Engineering, Systems Engineering, Technology or a related discipline.
* At least 3 years of industry experience in software engineering
* Software Validation and Equipment Validation experience in a regulated industry: FDA 21 CFR 820, the Quality System Regulation and ISO 13485.
* Experience of GxP Computerised Systems
* Understanding of GAMP5 Guidelines.
* Validation experience with ERP, CCMS/CMMS, and Quality Systems is preferred
* Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11 is required
* Strong knowledge of computerized system development life cycle approach is required
If this sounds interesting to you, please get back to me as soon as your earliest convenience.
Greetings from Zürich!
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