QA on the Floor - Senior Associate
| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | QualityOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3987 |
| Job Views | 29 |
- Description
Team Horizon is seeking candidates with a Quality on the Floor or Micro background on an initial 12-month contract for our Dublin based client who are a global leader in the field of biotechnology. You will report to the QA Manager, playing a pivotal role in the site's Quality Assurance team. As the Quality point of contact for manufacturing and inspection operations, the PQA Senior Associate will contribute to continuous improvement initiatives by undertaking additional responsibilities beyond routine QA duties.
Why you should apply:
- This is an excellent opportunity for someone with a Micobiology background who is interested in trasitioning into a QA position
What you will be doing:
- Ensure adherence to safety standards and SOPs in all activities.
- Review and approve production batch records and associated documentation for Qualified Person disposition activities.
- Provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities, including media fills and assessment of aseptic interventions.
- Conduct inspections of vials and syringes as part of AQLs, annual reserve inspections, and support complaint investigations.
- Offer Quality Assurance support for on-the-floor investigations and deviations.
- Review and approve deviations for closure, ensuring compliance with appropriate documentation.
- Participate in customer complaint investigations.
- Conduct routine Quality Assurance walks on the production floor.
- Review and issue logbooks, ensuring compliance with procedures.
- Provide training and guidance to staff for effective performance.
- Review and approve cGMP records, ensuring compliance with appropriate documentation.
- Support continuous improvement and Operational Excellence initiatives.
- Undertake other tasks/projects as assigned by the manager.
- Role supports 24/7 manufacturing so shift work is required and a shift premium is applicable
What you need to apply:
- University degree in an Engineering or Science-related discipline
- Over 4 years of relevant experience in the pharmaceutical or biotechnology industry or an equivalent combination of experience and educational background.
