Shift Plant QA Analyst – Med Device Assembly & Packaging

Job title:

Shift Plant QA Analyst – Med Device Assembly & Packaging

Company:

JobContax

Job description

Shift Plant QA Analyst – Med Device Assembly & PackagingOffice/Project Location: Dun Laoghaire, DublinEmployment Type: ContractWork Location: Site BasedPay: €30 – €40 per hourExperience: 3+ 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 Laoghaire, 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 report to a Senior QA Manager and is a core member of the site QA team.The QA Snr Associate will act as Quality point of contact for manufacturing operations and is responsible for oversight of:Medical Device assemblySerialized Packaging and labellingPerform all activities in compliance with safety standards and standard operating procedures.Observe and provide real-time quality oversight and support for manufacturing on the floor.Perform purposeful presence on the floor audits.Perform manual pack check and deft assessmentPerform Batch Review to support customer complaint investigationsProvide quality support for triage and investigation of all classes of deviation events.Review/approve deviations for closure ensuring compliance with appropriate standards.Review/approve production batch records, and associated documentation in preparation for qualified person disposition activities.Provides training and advice to staff in order for them to perform their desired functions.Write, review and approve standard operating procedures in accordance with company policies.Support continuous improvement and operational excellence initiativesAny other tasks/projects assigned as per manager’s request.Purposeful Presence on the floor:TriagePPOFDefect ClassificationPack ChecksAudit WalksQA Lock outsQuality ReviewLogbooksGMP DocumentationBatch RecordsDeviationsProtocolsRequirementsMinimum Qualification : Science Degree /Engineering degreeWe would like to see someone with a QPA backgroundBatch reviewsDeviationsOpen to considering candidates from a lab if they have deviation experience and demonstrate their ability to problem solve.Strong attention to detail in terms of task execution and QA review.Proven in Risk Based Decision Making – ability to assess both the impact of an event that occurs and the suggested path-forward.Excellent written and verbal communication skills – ability to communicate across different teams/backgrounds & up/down different levels with the organisation.Strong organizational skills, including ability to follow assignments through to completion – ability to work well on own and as part of a dynamic team.Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issuesOperational Excellence / Continuous improvement experience – ability to identify areas for improvement & implement said improvements.Problem solverAdvising and finding a complaint path forwardPrevious Production experienceAbility to do shift role 24/5 (at the moment shift schedule can change according to business needs, notice will of course be provided of ant change to cycle)We would like to see someone with a QPA backgroundBatch reviewsDeviationsOpen to considering candidates from a lab if they have deviation experience and demonstrate their ability to problem solve.PackageContract role – Hourly rate €30 – €40 per hourMinimum 12 month contract with the possibility of an extension.Onsite Expectations: 5 days per weekContract Durations: 12-monthsShift: As this is an onsite position, the successful candidate will be supporting a 25/5 shift pattern @ 25% rate.An example of one of the team’s shift patterns is as follows: Week 1: 2 days, 2 nights; Week 2: 3 days; Week 3: 3 nights.Candidates interested in the role should be mindful that there’s always a chance of needing to adapt to business needs, so we do need candidates who are open to doing 24/7 shift pattern.Eye Test Requirement: An eye test will be required on this occasion.ContactKaren McHugh is the consultant managing this position.If you are a Biotech QA Analyst interested in roles based in Dublin , you can contact Karen by e-mail at karen@jobcontax.com Karen or phone 353 1 7979720 for a confidential chat.JobContax do not send CVs to clients without candidate permission.With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Biotech QA Analysts in Dublin and Ireland.Due to the large volume of applications, JobContax may not be able to respond to every individual.taglife

Expected salary

€30 – 40 per hour

Location

Dublin

Job date

Wed, 29 Jan 2025 23:57:50 GMT

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