Are you a QC Systems Analyst with 4+ years experience owning Quality Records e.g.
Deviation Records, CAPA, ARA and Change Controls in the pharmaceutical or biotechnology industry?This is a contract role based in Dun Laoghaire, Dublin.If you have the relevant experience, please forward your CV to ****** for review or call 353 1 7978720 to discuss in confidence.QC Systems Analyst - Biotech Investigations - 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.QC Systems Senior Associate Investigations is a key member of the QC Systems team.
They provide support to the QC function for all activities within the site Quality System associated with QC Deviation Investigations, CAPA records, Analytical Results Assessments (ARA) and Change Controls.The successful candidate will own and manage the end-to-end life cycle of Quality records on behalf of Quality Control.
The role has a strong focus on technical writing and problem-solving including Root Cause Analysis and 5 Why methodologies.Triage ManagementQuality Record ownerTechnical writing for investigationsEnsure timely closure of Quality RecordsSME for Root Cause Analysis and 5 Why methodologiesDevelopment of robust CAPA and CAPA Effectiveness Verification in conjunction with area SMEsTrend Analysis of QC Quality recordsMonthly Metrics Management and ReportingParticipate in cross functional Investigations TeamsLead Continuous Improvement InitiativesContribute to success of QC GoalsSupport NPI/ Lot Release / Stability linked to Quality RecordsParticipate in Regulatory InspectionsOwnership of Change Controls Key Values and Competencies:Work in Teams; Ensure Quality; Be Science Based; Collaborate, Communicate and Be AccountableAbility to work through Complex ProblemsExcellent verbal and written communication skills including technical writing, presentation, and facilitation skills.Ability to work in a fast-paced environment with changing prioritiesComfortable working under minimal directionRequirementsHold a third level qualification in a science related disciplineHave a minimum of 4 years experience in Biopharmaceutical/ Pharmaceutical industries or 2 years in a similar investigator roleExperience owning Quality Records e.g.
Deviation Records, CAPA, ARA and Change Controls advantageousPossess key competencies to include planning/organization, problem solving, excellent verbal and written communication, teamwork, flexibility and adaptabilityPackageContract role - Hourly rate €30 - €36 per hourMinimum 12 month contract