Senior Quality Assurance Specialist (hybrid)
RK4761
Contract 12 months
Dublin



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Duties:

• Provide overall quality direction and oversight for key functional areas (i.e. Inspection, Validation, Quality Control, Engineering, ), ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations.
• Quality review and approval of Validation documentation and SOPs to support site validation activities:
• Review of DS & QRAES documents
• Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
• Review of executed validation documents and reports
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
• Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
• Perform all activities in compliance with company safety standards and SOPs
• In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role

• University degree in an Engineering or Science-related discipline (preferred).
• Over 6 years of relevant experience in the pharmaceutical or biotechnology industry
• Understanding of principles of Validation and New Product Introduction
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.