This leading global speciality pharmaceutical company are focused on providing therapies to unmet patient needs. They are a market leader in development, with a diverse portfolio across branded products and generics, as well as API products.

They are seeking an experience QA Validation Specialist to support operation of their core quality systems at their state-of-the-art manufacturing facility in North Dublin, and provide QA/Validation support to both manufacturing operations and lab operations.

The Role

Duties and responsibilities of the QA Validation Specialist will include:

• Provide expertise in the area of validation ensuring compliance with current industry regulations, guidelines and trends
• Reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations,SOPs, specifications etc
  • Qualification of premises, equipment and utilities
  • Computer system qualification
  • Laboratory equipment validation
  • Process validation
  • Cleaning validation
• Ensure change controls are assessed for impact on validation
• Review and Approval validation master plans
• Execute validation protocols when required, including preparation of, and review of, deviations associated with validation activities
• Oversee investigations, out of specification and unplanned events workflows to ensure they are performed correctly, assist in Root Cause Analysis investigations as required
• Oversee change control management process ensuring impact of proposed changes are adequately assessed how the implementation is managed
• To conduct supplier audits, Internal audits and co-ordinate regulatory audits
• Perform batch review and approval of release documentation

The Person

You will have skills and experience in the following:

• BSc in scientific discipline
• 3+ years experience in a QA Validation / QA Specialist position in pharmaceutical manufacturing
• Experience working with Quality Systems such as Deviations, Change Controls, Training, Supplier Qualification and Document Management systems required
• Ability to work independently
• Collaborator with strong levels of engagement with individuals and team
• Strong organisational skills

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.