Job Title: Quality Assurance Operations (Hybrid)
This is an exciting opportunity to join an award-winning Pharmaceutical organization based in Meath.
Duties:
* Lead, facilitate and participate daily on cross-functional teams to collaboratively address compliance issues and achieve project milestones.
* Participate in investigations and risk assessments related to deviations/complaints and changes, ensuring appropriate actions are implemented timely.
* Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs and related documentation for compliance to GMP and site requirements at the facility.
* Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations at the facility.
* Complete QA operational duties related to product disposition including incoming material release and the performance of detailed review of eBR prior to QP release.
* Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required.
* Assist in the development of training curricula and records for the QA Operations Group, providing SME training on Quality Assurance SOPs as required.
* Assist in the creation and maintenance of QA policies, SOPs and reports in line with site requirements.
* Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
* Participate in and support risk management activities in line with relevant guidance and best industry practice.
* Assist in the execution of the internal audit programme including the performance of audits as required.
* Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture.
* Ensure the escalation of compliance risks to management in a timely manner.
Experience and Education:
* Degree qualification (Science/Quality/Technical).
* 8-10 years' experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
* Project Manager capability with significant understanding of Operations.
* Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
* Strong written and verbal communication skills.