Job Title: QA Operations Specialist
Job Summary
This is a fantastic opportunity for a skilled QA Operations Specialist to join our client, a leading Pharmaceutical company located just outside of Dublin.
Key Responsibilities
* Lead Quality Assurance, ensuring strong operational compliance and alignment with cGMP regulations
* Maintain cGMPs for assigned areas, providing quality support and training on regulatory requirements
* Participate in investigations, risk assessments, and change controls to ensure timely actions
* Provide QA review and approval of documentation, including Change Controls and SOPs
* Evaluate new regulatory guidance and industry best practices, identifying updates for Quality systems
* Develop and maintain QA policies, SOPs, and reports, and assist in the creation of training curricula
Requirements
* Degree qualification in Science, Quality, or Technical field
* 8-10 years of experience in Quality Assurance, Technical Operations, or Quality Control within the pharmaceutical industry
* Project Manager capability with strong understanding of Operations
* Demonstrated experience in QRM, Investigations, and Problem solving as a Quality SME
* Strong written and verbal communication skills
* Experience in quality management systems such as Veeva, SAP, and PAS-X
* Demonstrated knowledge of industrial regulations, including FDA, HPRA, EMEA, and other authorities related to Biologics and/or Pharmaceuticals