Quality Assurance Expert
This is an exciting opportunity to work with a leading multinational organization in Dublin. The role involves providing quality direction and input at Change Control and Deviation Review Boards and assuming QA oversight of change control and Deviation/CAPA records.
Duties:
* Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring all activities meet company and regulatory expectations.
* Quality review and approval of Process Development and Validation documentation including 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 safety standards and SOPs.
* In line with business requirements, responsibilities may expand or include additional areas of responsibility not described in this specification but associated with the role.
Educational Requirements:
* University degree preferably in Engineering or Science related discipline.
* Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that satisfies the requirements of the role.
* Understanding of principles of Validation and New Product Introduction.