Senior Quality Assurance Analyst - PTQA - Dun Laoghaire, DublinAre you a Quality Assurance Analyst with 7+ years 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)?This is a contract role based in Dun Laoghaire, Dublin.Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.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.Act 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 Amgen and regulatory expectations.Quality review and approval of Process Development and Validation documentationTechnical transfer documentsValidation Protocols, executed validation documents and reportsProvide 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 Amgen safety standards and SOPsRequirementsUniversity degree.
Science or Engineering related discipline preferred.Understanding of principles of Validation and New Product IntroductionExperience in aseptic manufacturingRelevant 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.PackageContract role - Hourly rate €55 - €67 per hourMinimum 12 month contract
