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CSV SME

  1. Ireland, Dublin
Dublin
  1. Contract
Competitive
  1. CAPEX Projects
36855
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CSV SME - Dublin, Ireland - 6 Months Contract

How would you like the opportunity to work with in one of the largest bio-pharmaceutical projects in the country? If yes, then this is the assignment for you!

Our client is currently seeking the skills of CSV SME to join their team. Our client develops and delivers life changing medicines to millions of people globally and as part of their growth. With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!

Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Site Subject Matter Expert for Computerised Systems Validation.
  • Responsible for developing and managing the site strategy towards CSV.
  • Develop and manage risk-based testing strategies for computerised systems, to ensure that potential risks to product quality are appropriately managed.
  • Ensure that computerised systems lifecycle requirements are embedded within computerised systems projects.
  • Support vendors to ensure adherence to, and application of GAMP
  • Manage risk-based execution to ensure test data may be leveraged from commissioning testing into qualification.
  • Work cross-functionally to ensure site alignment with lifecycle requirements.
  • Support development of CSV competencies within both Validation and across the business.
  • Ensure you and the personnel (internal and external) operating under your remit comply with all applicable Environment, Health & Safety requirements.
  • Collective responsibility for the ongoing compliance of all assets at the Elstree facility within your remit, ensuring that the equipment meets regulatory requirements at all times with a target of zero impact to routine operations.
  • Maintain an ongoing dialogue with Validation Management to ensure validation resources are effectively deployed to meet dynamic and competing business priorities.
  • Support the implementation validation strategies that allow the work to be executed by the most appropriate personnel (internal and external) whilst maintaining standards.
Desirable Experience:
  • Pharma experience
  • Data Integrity
  • (EBR) Electronic Batch Record Systems
  • Writing URS’s
  • Stakeholder management
  • Reviewing and Approving SAT’s & FAT’s
If this role is of interest to you, please apply now!
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