QA Specialist

PE Global is currently recruiting for a QA Specialist for a leading multi-national Biotech Pharma client based in Dunboyne, Co Meath.
This is an 11 month contract position.
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 Microbial and Analytical Method Validation, Analytical/ Microbial Technical Transfers, Regulatory approvals, Clinical and Commercial operations at the facility.
• Support QA operational duties related to product disposition including the performance of detailed review of eBR prior to QP release and Material release.
• 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.
• Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture in BioNX.
• Ensures the escalation of compliance risks to management in a timely manner
Requirements:
• Degree qualification (Science/Quality/Technical).
• 5-10 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.

Interested candidates should submit an updated CV.
Please click the link below to apply or alternatively send an up to date CV to niamh.mcdonald@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***