Senior Quality Assurance Specialist
We are recruiting for an exciting opportunity with a leading Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a multinational.
Job Description:
* 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.
Required Skills & Qualifications:
* University degree in an Engineering or Science-related discipline (preferred).
* Over 4 years of relevant experience in the pharmaceutical or biotechnology industry.
* Demonstrated problem-solving abilities, particularly in supporting non-conformance/deviation investigations.
* Experience in inspecting vials and syringes and engaging in aseptic operations.
About this Role:
This is a challenging and rewarding role that requires a high level of technical expertise and attention to detail. The ideal candidate will be able to demonstrate strong problem-solving skills and experience working in a fast-paced environment.