QA Analyst - Incoming Inspection - Dun Laoghaire, DublinAre you a QA Analyst with 4+ years working in the pharmaceutical or biotechnology industry and demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations?This is a contract role based in Dun Laoghaire, Dublin.QA Analyst - Incoming Inspection - Dun Laoghaire, DublinOur 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.You will be an active member of the QA team and will be assigned to the IQA Quality functional area, which is responsible for the inspection and release of primary packaging components.
You will report to a QA Senior Manager and will serve as Quality point of contact for Incoming Inspection of Primary and packaging components.The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, you may be asked to carry out additional work functions to support site continuous improvement activities.Testing of primary and secondary components for use in the manufacture of aseptic products.Sampling of Excipients and Drug Substance under Grade C conditions.Review/approve documentation associated with component testing in preparation for QA Specialist or Qualified Person disposition activitiesCompiling, Review and approval of minor NC and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievableProvide training and advice to staff in relation to testing of components and packaging.Actively participate in audits and their preparation.Review cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.)
ensuring compliance with appropriate documentationWrite, review and approve Standard Operating Procedures in accordance with Policies.Perform all activities in compliance with safety standards and SOPsSupport continuous improvement and Operational Excellence initiativesAny other tasks/projects assigned as per manager's request.RequirementsMust Pass Eye-Tests required for Visual InspectionUniversity degree.
Engineering or Science related discipline preferred4 + years working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.Excellent written and verbal communication skillsExperience working with dynamic cross-functional teams and proven abilities in decision makingStrong organizational skills, including ability to follow assignments through to completionDemonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigationsExperience working in aseptic operations, protein formulation, vial and syringe filling.PackageContract role - Hourly rate €30 - €35 per hourMinimum 12 month contractExpectations are to be onsite FIVE days a week and it'll also be a shift role.We will have people coming in from 07:00 to 15:00, Monday to Thursday, 07:00 to 14:00 on a Friday.Late shift is from 14:30 to 10:30 Monday to Thursday, 13:30 to 08:30 on a Friday.
