Validation Specialist

Posted 9 May by Marketplace Group Easy Apply

International Pharmaceutical Manufacturer seeks a Computer Systems Validation (CSV) Specialist As part of the Validation team, you will be taking ownership of all aspects of service delivery which relate to equipment commissioning, qualification and validation within your remit. You will be ensuring compliance with all applicable (EHS and GxP) regulatory and internal Quality standards and industry best practice. You will need to be committed to, and passionate about providing a reliable and compliant service to meet and exceed the customer's needs. This is a customer-facing role, and as such the ability to form relationships across the organisation is essential for success.

Essential Skills :

  • Must have worked within a in CSV Validation environment.
  • In depth knowledge of the requirements and expectations of GAMP 5 and its practical application.
  • Full conversant in the requirements and expectations of 21 CFR Part 11 and Annex 11 and their practical application.
  • Have significant experience in the validation of enterprise systems and/or control systems.
  • Practical hands-on experience of executing CSV.
  • You understand, can clearly explain and would be able to train others in CSV
  • Collective responsibility for the ongoing compliance of all assets at the Hertfordshire 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.
  • Highlight risks to product quality, patient safety and/or data integrity throughout the validation lifecycle so that they are understood, transparent and can be managed through the application of a quality risk management approach.

Reference: 35102164

Bank or payment details should not be provided when applying for a job. reed.co.uk is not responsible for any external website content. All applications should be made via the 'Apply now' button.

Report this job