QA Operations Specialist (hybrid)
RK23040
Contract – 11 months
Meath


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Meath. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


This role involves 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. The role will be responsible for maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations. The Quality Assurance Operations Specialist will provide quality support to the site, including training and guidance on the interpretation and implementation of company Guidelines / Policies and regulatory requirements, as required


Duties:

• 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.


Educational and 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.


If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.