Validation CSV Engineer / Specialist

DPS Alban Technical Limited
£35k - £55k pa + Negotiable
03 Oct 2017
05 Nov 2017
Contract Type
Full Time
CSV Specialist - Medical Devices - West Sussex - Competitive Salary Our Client a specialist in the medical device industry is seeking a CSV Specialist to join the Company on a permanent basis. The successful candidate's objectives will be to assist with the implementation of a Computerised System across the Company and to work in partnership with other departments to drive efficiency improvements within CSV tasks. Key Responsibilities and Performance Indicators - Determining validation requirements for computerised systems and manufacturing systems in accordance with a risk based approach - Manage all validation activities. - Provide technical input into regulatory submissions / regulatory enquiries - Provide guidance to project teams - Preparation and completion of validation documentation / protocols - Establishing a professional relationship with suppliers - Producing documentation to the required quality and agreed timelines (validation plans, validation protocols, testing rationales, reports, etc.) - Reviewing and approving supplier's documentation to the required quality and agreed timeline - Raising awareness of CSV across all levels of the company Experience - Working knowledge of ERP systems and other business systems - Working knowledge of GAMP5 is advantageous - Experience working within the Medical Device, Pharmaceutical or similar regulated industry
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