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QA Validation Specialist

QA Validation Specialist (QAVALSPE-TUL-0103) Tullamore, Republic of Ireland

  • Support continuous validation and compliance to the Site Validation Master Plan including compliance with cGMP; Facilities, Equipment, Utilities, Laboratory Methods, Process, computerized Systems.
  • Support deviation management including validation deviations and deviations that impact qualification/validation at the Tullamore site.
  • Interface with the QC/QA/Warehouse/Production and Engineering departments to identify projects and problems requiring validation support.
  • Provide QA/compliance support to Cross functional teams to ensure that activities associated facility qualification and transfer of new products are in compliance with regulatory, corporate and site procedures and reviewing and approving transfer protocols, summary reports, strategy documents, qualification documentation, change control related documentation, master batch records etc.to support new product introduction.
  • Coordinate validation and IQ/OQ/PQ activities with Production, Warehouse, Quality Control Laboratories, Engineering and outside contractors providing leadership, training and guidance as required
  • Monitor and support the execution of the protocols through training, facilitating and problem-solving activities.
  • Participate in site data integrity program and support the onboarding of computer systems to Zoetis Tullamore e.g. Empower 3, other Lab/Production Operational computerized systems.
  • Support validation activities to ensure they consistently remain in place, in use and in control, comply with Zoetis Global Quality Policies and Standards and meet the most current regulatory requirements and best industry practices.
  • Support Internal and External Factors Impacting Validation System (i.e., emerging regulations, innovations that might enhance the pharmaceutical quality system), to ensure compliance with the change regulatory environment.
  • Immediate notification to the QA Validation Manager of any quality issues and provide accurate and relevant information as required by the business.
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