LSC have a great opportunity for a Senior QA Specialist to join the QA team in a South Dublin-based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 4+ years of experience providing technical QA support to pharmaceutical or biotech manufacturing operations and are ready for your next challenge, this could be the perfect project for you!
About the role:
Note: This is a 24/7 Shift role - 4 on 4 off
- Key Responsibilities:
* 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.
About you - Are you a skills match?
- * University degree in an Engineering or Science-related discipline (preferred).
* Over 4 years of relevant experience in the pharmaceutical or biotechnology industry or an equivalent combination of experience and educational background
Apply directly via this advert or contact Siobhan Cummins on 021 4718212 if you have any more questions about this opportunity!
Please note that we are unable to provide work permit or visa sponsorship.
