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Computer System Validation Engineer - Technical Writer - GXP - Pharma
Eingestellt von Coopers Group GmbH
Gesuchte Skills: Engineering, Support, Engineer
Projektbeschreibung
For our client, a dynamic and multinational pharmaceutical company in Basel, Switzerland, we are looking for a motivated and ambitious:
COMPUTER SYSTEM VALIDATION ENGINEER/TECHNICAL WRITERto support rollout of Beamex CMX calibration application solution to Clients IT sites:
MAJOR ACCOUNTABILITIES
- 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
MAIN REQUIREMENTS
- 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
DURATION: 02.11.2015 - 29.04.2016 (EXTENSION OPTIONAL)
COMPUTER SYSTEM VALIDATION ENGINEER/TECHNICAL WRITERto support rollout of Beamex CMX calibration application solution to Clients IT sites:
MAJOR ACCOUNTABILITIES
- 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
MAIN REQUIREMENTS
- 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
DURATION: 02.11.2015 - 29.04.2016 (EXTENSION OPTIONAL)
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges