Senior QA Specialist

Summary: A Senior QA Specialist is required for a biopharmaceutical company in South Dublin. The successful candidate will act as Quality point of contact during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet regulatory expectations. 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 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 our Client’s 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.
• 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 aseptic manufacturing.
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
• Understanding of principles of Validation and New Product Introduction