Senior Quality Assurance Specialist

Orion Group Life Sciences are currently recruiting a Senior Quality Assurance on behalf of our Multinational Biotechnology Client based in South Dublin on an initial 12-Month contract with huge potential to extend.
The Plant Technical Quality Assurance (PTQA) Specialist is a senior position within the QA function which will typically report to a QA Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
Key ResponsibilitiesAct 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 the safety standards and SOPs.Preferred QualificationsUniversity degree. Science or Engineering related discipline preferred.Understanding of principles of Validation and New Product Introduction.Experience in aseptic manufacturing.Relevant experience (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 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.
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