Quality Assurance Operations Specialist Lead

2 weeks ago


Co Meath, Ireland Life Science Recruitment Ltd Full time

We are seeking an experienced Quality Assurance Operations Specialist to join our team at Life Science Recruitment Ltd. In this role, you will be responsible for maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs and Health Agency regulations.

Responsibilities
  • Lead daily cross-functional teams to address compliance issues and achieve project milestones.
  • Participate in investigations and risk assessments related to deviations/complaints and changes.
  • Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs, and related documentation.
  • Provide QA oversight to qualification/validation, technical transfers, regulatory approvals, and commercial/clinical operations.
  • Evaluate new and prospective regulatory guidance and industry best practice.
Requirements
  • Degree qualification in Science/Quality/Technical.
  • 8-10 years experience 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.

This is an excellent opportunity for anyone looking to join a leading multinational in the Pharmaceutical organization. If you are interested in this role, please feel free to contact Rachel Kent at Life Science Recruitment for further information.



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