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CSV/Computer System Validation Specialist
CSV Specialist is required by our global pharmaceutical client to perform and provide expertise in the development, co-ordination and execution of computer systems validation, in line with GxPs, Reg Requirements and procedures.
CSV Specialist will:
*Produce CSV plans, qualification test protocols, traceability matrices
*Assist in development of system requirements and specs to ensure requirements that are testable
*Ensure appropriate validation of the new GxP computer systems
*Conduct a data integrity audit/review of proposed solutions and advise of any remediation activities
CSV Specialist will need:
-Strong background in IT within an FDA/MHRA regulated environment
-Complete understanding and proven experience of CSV and 21 CFR part 11 compliance and annex 11
-Knowledge of GxP, GAMP and regulatory guidelines
-Knowledge of data integrity practices
-Experience in validation of SaaS solutions
-Outstanding interpersonal and communication skills
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