Are you a Senior PQA Associate with 4+ years of biopharmaceutical experience.Do you have knowledge and experience in managing Root Cause Analysis / Deviation investigationsIf you have the relevant experience, please forward your CV to ****** for review or call 353 1 7978720 to discuss in confidence.QA Specialist - Biotech PQA - DublinJob Description 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 Quality Assurance (QA) Senior Associate will report to a QA Manager and is a core member of the site Quality Assurance team.
Quality point of contact for Plant Quality Assurance (PQA).
The site is focused oncontinuous improvement of all work processes and practices, therefore in addition toroutine Quality Assurance duties, QA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities.
This is a 24/7 shift role required to support manufacturing operations.The Plant QA team structure is one group responsible for oversight of aseptic manufacturing (Formulation and Fill) and for oversight of the Inspection and Packaging operation.Key Responsibilities:Perform all activities in compliance with Amgen safety standards andstandard operating procedures.Observe and provide real-time quality oversight and support formanufacturing on the floor.Perform purposeful presence on the floor audits.Perform manual visual inspection AQL audits of vials and syringes.Perform QA reserve sample inspections as part of the annual reserveinspection program and in support of customer complaint investigationsCertification of defect panels.Provide quality support for triage and investigation of all classes of deviationevents.Review/approve deviations for closure ensuring compliance with appropriatestandards.Review/approve production batch records, and associated documentation inpreparation for qualified person disposition activities.Provides training and advice to staff in order for them to perform their desiredfunctions.Write, review and approve standard operating procedures in accordance withour clients policies.Support continuous improvement and operational excellence initiativesAny other tasks/projects assigned as per manager's request.Basic Qualifications & Experience:University degree.
Engineering or Science related discipline preferred.Relevant experience (4 years +) working in the pharmaceutical orbiotechnology industry or other combination of experience and educationalbackground that may otherwise satisfy the requirements of the role.Preferred Qualifications & Experience: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 RootCause Analysis / Deviation investigationsInternal Use Only General and AdministrativeKnowledge of applicable Regulatory requirements, and ability to evaluate compliance issuesOperational Excellence experiencePackageCompetitive salary depending on experience