QA Specialist
1 day ago
QA Specialist - Technical Support, Dun Laoghaire, DublinOffice/Project Location:Dun Laoghaire, DublinEmployment Type: ContractWork Location: Hybrid, one day a week on sitePay: €50 - €58 per hourExperience: 7+ yearsVisa: EU passport or Stamp 4 visa requiredOur 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 Quality Assurance Technical Support (QA TS) Specialist is a 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.Provide overall quality direction and oversight for key functional areas (i.e. Inspection, Validation, Quality Control, Engineering, ), ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations.Quality review and approval of Validation documentation and SOPs to support site validation activities:Review of DS & QRAES documentsReview of validation Plans, Protocols, IQ, OQ, PQ and associated validation documentsReview of executed validation documents and reportsSupport a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulationsProvide 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 safety standards and SOPsIn 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 roleRequirementsUniversity degree. Science or Engineering related discipline preferred.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. Packaging, Inspection, Validation, Quality Control, Engineering, Information Systems)Understanding of principles of Validation and New Product IntroductionExperience 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 €50 - €58 per hourMinimum 12 month contractWork location: This is a hybrid role, so the preference here is for local candidates or candidates within a commutable distance to the site. The expectation is for the successful candidate to be onsite at least once a week.
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