JobContax
Job title:
Biotech QA Analyst
Company:
JobContax
Job description
Biotech QA Analyst – Dun Laoghaire, DublinOffice/Project Location: Dun Laoghaire, DublinEmployment Type: ContractWork Location: HybridPay: €30 – €35 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.The Plant Quality Assurance (PQA) Snr Associate will report to the QA Manager and will be a core member of the site Quality Assurance team.The PQA Snr Associate will serve as Quality point of contact for manufacturing operations.The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA 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.Perform all activities in compliance with safety standards and SOPs.Write, review and approve Standard Operating Procedures in accordance with Policies.Provide Quality support for triage and investigation of all classes of non-conformance (NC) events.Review and approval of deviations for closure ensuring compliance with appropriate documentation.Participates in customer complaint investigations.Provides training and advice to staff in order for them to perform their desired functions.Observe and provide real-time quality oversight, and support for production unit operations, extending to formulation, vial and Syringe Fill Finish related activities, including observation and provision of direction during media fills and assessment of aseptic interventions.Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.Review and approve cGMP records ensuring compliance with appropriate documentation.Support continuous improvement and Operational Excellence initiatives.Any other tasks/projects assigned as per manager’s request.RequirementsUniversity degree. Engineering or Science related discipline preferred.Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.Septic Experience would be great to see.Experience in manufacturing of syringes or liquid products.Somebody who can follow procedures and is comfortable changing priorities for business needs.Must have a Science Degree as a minimum to be considered for the roleExcellent written and verbal communication skills.Experience working with dynamic cross-functional teams and proven abilities in decision making.Strong organizational skills, including ability to follow assignments through to completion.Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations.Experience working in aseptic operations, protein formulation, vial and syringe filling.Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.IMPORTANT: there is an eyesight test that they must pass before we can proceed with an offer.PackageContract role – Hourly rate €30 – €35 per hourMinimum 12 month contract with the possibility of an extension.24/7 shift pattern and would have to have people who are willing to do shift work.Shift rate: 35%This works by two shift patterns, 7:00 to 19:00 and 19:00 to 7:00.So they do four days on and they get four days off and it crosses over the weekend.Also, they get three hours extra a week for working on social hours.IMPORTANT: there is an eyesight test that they must pass before we can proceed with an offer.ContactKaren McHugh is the consultant managing this position.If you are an 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 – 35 per hour
Location
Dublin
Job date
Wed, 02 Apr 2025 22:58:35 GMT
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