I'm currently working with a leading global pharmaceutical company that is growing its QA function at a high-performing manufacturing site in Tipperary. This is an excellent opportunity for an experienced Quality Assurance Specialist to step into a senior-level position with a strong focus on GMP compliance and quality oversight.
The Opportunity:
* Join a globally recognised pharma organisation known for operational excellence and innovation.
* Contribute to the release of both drug substance and drug product, with involvement in QP support.
* Work cross-functionally to drive compliance, resolve quality issues, and enhance systems.
* Be part of a collaborative QA team where your experience will have real impact on product quality and patient safety.
Key Responsibilities:
* Review and approve production and analytical documentation to support QP certification.
* Investigate deviations, complaints, change controls, and CAPAs in a timely, thorough manner.
* Support internal audits, quality improvement initiatives, and product recall processes.
* Maintain and create SOPs and compile data for reporting and presentations.
* Build strong relationships across departments to ensure compliance and continuous improvement.
* Stay current on global GMP regulations and represent QA in cross-functional teams.
Candidate Profile:
* Degree qualified in a Science or Engineering discipline (or equivalent industrial experience).
* Demonstrated experience in a regulated GMP manufacturing environment, preferably pharma or biopharma.
* Strong knowledge of quality systems, regulatory compliance, and technical documentation.
* Proven ability to work independently and collaboratively in a fast-paced setting.
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