QA Operations Specialist
Fantastic opportunity for a QA Operations Specialist to join our client, a leading Pharmaceutical company located just outside of Dublin.
Role
The QA Operations Specialist will lead Quality Assurance, being a key member of the quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of cGMP regulations.
Responsibilities
* 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.
* Complete QA operational duties related to product disposition including in-coming material release and the performance of detailed review of eBR prior to QP release.
* Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations at the facility.
* 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.
* Participate in and support risk management activities in line with relevant guidance and best industry practice.
* Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
* Ensure the escalation of compliance risks to management in a timely manner.
* Assist in the execution of the internal audit programme including the performance of audits as required.
* Work collaboratively to promote strong relationships with management and colleagues while driving a safe and compliant culture.
Requirements
* A Degree qualification (Science/Quality/Technical).
* 8-10 years of experience, ideally in Quality Assurance, Technical Operations or Quality Control within the Biological and/or pharmaceutical industry.
* Project Manager capability with strong understanding of Operations.
* Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
* Strong written and verbal communication skills.
* Experience in quality management systems such as Veeva, SAP, PAS-X etc.
* Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
* Strong attention to detail and accuracy in preparing and reviewing GMP documentation.
* Experience in direct interactions with regulatory authorities during site inspections.