Headcount Solutions Limited

Senior QA Specialist (BB-49D25)

Found in: Neuvoo IE

Senior QA SpecialistThe Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function of a leading Dublin based biopharmaceutical manufacturer. The successful candidate will be required to be a Subject Matter Expert in their assigned area of responsibility.Key Responsibilities• 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 whilst ensuring that all activities meet Amgen and regulatory expectations.• Provide Quality direction and input at Change Control Review Board and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.• Write, review and approve Standard Operating Procedures in accordance with site policies.• Perform all activities in compliance with site safety standards and SOPsPreferred Qualifications• University degree. Science or Engineering related discipline preferred.• Understanding of principles of Validation and New Product Introduction• Relevant experience (5yrs +) 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.• Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.For more information and a full job spec contact Nicola

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