An opportunity for a Senior QA Specialist has arisen with a renowned Dublin based biopharmaceutical multinational. The successful candidate will provide overall quality direction and oversight for key functional areas including Process Development, Validation, QC, Supply Chain, Information Systems.
This is an excellent opportunity to progress your career within a dynamic and fast paced environment.
• Quality review and approval of Process Development and Validation documentation
• Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities.
• Provide Quality direction and input at Change Control Review Board and assume QA oversight of change control and Deviation/CAPA records.
• Write, review and approve Standard Operating Procedures in accordance with site policies.
• Perform all activities in compliance with site 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
• Relevant experience (10yrs +) 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, Quality Control, Supply Chain, Engineering, Information Systems)
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
• Ability to operate across functional boundaries, both internal and external.
• Ability to work independently and remotely with minimum direct supervision.
• Critical thinking skills.
• Strong organisational, communication, coordination, and meeting facilitation skills.
• Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.