Quality Validation Specialist

Job Overview

Our client, a multinational company based in Little Island, is looking for a quality assurance validation specialist. This brand new role has come about to support major projects in the facility.
Do you have an Engineering Degree?
Do you have QA Validation experience?
Your duties will include:

  • Responsible for managing the review and approval of commissioning documentation, validation protocols, reports and support records to certify compliance with specifications and procedures.
  • Act as Quality contact and Subject Matter Expert (SME) for Validation and Quality Risk Management from Quality perspective in supporting sites validation
  • Reviews and approves the validation approach and protocol results
  • Reviewing and/or approving validation documents (validation master plans, validation plans, protocols, reports, commissioning and qualification documents) and SOPs ensuring compliance to site SOPs and good practice
  • Coordinate with Validation to ensure that Validation activities are appropriately planned to coincide with the overall project implementation
  • Quality Validation impact assessment regarding changes to validated systems and processes.
  • Reviews and approves protocols to ensure they meet current regulatory requirements and industry practices
  • Provides technical support and guidance to other project team members in protocol preparation/review, execution from a quality assurance aspect. interpretation
  • Reviews and approves change requests, ensuring they will not lead to breach of GMPs
  • Participates in inspection activities for quality signoff of protocol prior to hand back of equipment to manufacturing.

If you have a degree coupled with 3/5 years Quality Validation experience, and you would be interested in hearing about this exciting new job in Cork, please apply for the job by sending in your cv and I will contact you to discuss this further.
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