Senior Quality Assurance Specialist (Tech Transfer)
Hybrid
RK5464
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.



Key Responsibilities:

• Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet company and regulatory expectations.
• Quality review and approval of Process Development and Validation documentation
• Technical transfer documents
• Validation Protocols, executed validation documents and reports
• 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. Science or Engineering related discipline preferred.
• Understanding of principles of Validation and New Product Introduction
• 7yrs + working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing)
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
• Experience in aseptic manufacturing