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CSV Specialist - Dunstable - Permanent - £55,000 - £63,000

Posted on Jan 30, 2020 by Lucid Support Services Ltd

Dunstable, Bedfordshire, United Kingdom
IT
10 Feb 2020
£55k - £63k Annual
Full-Time

CSV Specialist - Dunstable - Permanent - £55,000 - £63,000

We have an exciting opportunity for a CSV Specialist to join a global medical distributor and manufacturer in Dunstable. The successful candidate will work on the global framework for Computerized Systems Validation (CSV) of IT systems being compliant while handling quality GxP data within regulatory standards. This is a fantastic opportunity for anyone looking to join a globally successful company to help develop the quality and regulatory compliance.

You will be the key contact in the IT-CSV and QSR-CSV set up, working with a various stakeholder across the business and externally.

Key Skills

  • Strong understanding of Computerized System Validation (CSV)
  • Degree - preferably in IT engineering/Computing or equivalent
  • Qualification in Business Systems Analysis or experience reviewing documentation for quality systems.
  • Strong understanding of the Software development life cycle
  • Experience with CAPA Systems (or other Quality systems)
  • Stakeholder management
  • Experience Delivering Training
  • Knowledge regulations and standards (ISO 9001, ISO 13485, FDAs QSR and Part 11 and Part 820) or willingness to develop knowledge
  • Sound Knowledge of GAMP's: (Global Information Systems, IT Infrastructure Control and Compliance, A Risk-Based Approach to Compliant Electronic Records and Signatures, Validation of Laboratory Computerized Systems, Testing of GXP Systems)

Key Responsibilities

  • Create and preserve CSV procedures, documents and Quality Policies and Guidelines, and SDLC documentation.
  • Discuss and coordinate with all IT functions to validate systems
  • Work on and impact Change Control Process, Impact Analysis and Risk Assessments
  • Organise and oversee yearly reviews
  • Oversee the maintenance of systems ensuring they are in a validated state via change control
  • Training material and delivery
  • Perform internal and external audits

Reference: 835083496

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