Beschreibung
BRINE SA is currently seeking for a Computer System Validation engineer/Technical writer to support rollout of Beamex CMX calibration application solution to TechOps IT sites.
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
Interested? If yes, then please send me your Curriculum Vitae
Work location: Basel
Start: 02.11.2015 to 29.04.15
Duration: 6 months
Permits required: EU citizen or valid work permit
Workload: 100%
Language: English
Ref: PD1895
BRINE SA has been providing its IT- and SAP specialists for short-, mid- and long-term projects in Switzerland since 1985, with customers primarily active in the following market sectors:
Financial services sector, especially banks and insurance companies
Pharmaceutical industry
Government and services sectors
BRINE SA is a stable, financially independent, Swiss enterprise with its head office in Zurich. Our services cover the entire IT spectrum, as well as interfaces to the various business sectors, and range from management- and IT-consulting through to software development and project implementation.
IT - Resources
We offer our top consultants, computer profis and SAP experts to our customers as external specialists for limited assignments and as well for permanent positions. BRINE SA is especially distinguished by its renowned characteristic strengths:
Short reaction time - rapid selection and supply of consultant's CVs, with skills matched to customer requirements.
Quality - we take quality very seriously, both for internal and external-facing processes, thereby convincing many customers to maintain a long-standing business relationship with BRINE SA
Coaching - BRINE SA coaches and supports its consultants throughout the entire duration of the customer assignment.
BRINE SA is ISO 9001:2008 certified since 2012