Senior Technical Support Specialist Role
This is a senior position within the quality assurance function, reporting to a QA Manager.
The role involves being a Subject Matter Expert in assigned areas of responsibility and providing quality direction and oversight for key functional areas.
* Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer, and Process Validation activities.
* 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.
Requirements:
* University degree in Science or Engineering related discipline.
* Understanding of principles of Validation and New Product Introduction.
* Experience in aseptic manufacturing.
* Relevant experience working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas.
Desirable Skills:
* Critical thinking skills.
* Strong organisational, communication, coordination, and meeting facilitation skills.
* Independent, self-motivated, organised, able to multi-task in project environments and skilled in communication and collaboration.
This role presents an exciting opportunity to join a leading biotech company in Ireland.