Lead QA Specialist – Operations – Co. Meath

Excellent Hybrid Quality opportunity is available in Co. Meath,

This role will suit  someone with at least 8 years experience gained in a lead / Management role within a GMP Biopharmaceutical environment.

Role:

• 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.

Skills:

• 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