QA Operations Specialist (Hybrid)

Summary:
A QA Operations Specialist is required for a biopharmaceutical company in Dunboyne. The successful candidate will be responsible for maintaining cGMP’s for assigned areas in conformance with policies and in compliance with cGMP’s and Health Agency regulations and all other applicable governing regulations. The incumbent will provide quality support to the site, including training and guidance on the interpretation and implementation of company guidelines, policies and regulatory requirements. This is a hybrid role.

Responsibilities:

• Lead, facilitate and participate daily on cross-functional teams to collaboratively actively to 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 in-coming 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, SOP’s 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 are required.
• Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture.
• Ensures the escalation of compliance risks to management in a timely manner.

Qualifications & Experience:

• 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.
• 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.
• Experience in direct interactions with regulatory agencies during site inspections.
• Strong attention to detail and precision in preparing and reviewing GMP documentation.