PE Global is currently recruiting for a QA Compliance Specialist – Supplier Quality on behalf of our client based in North Dublin:
Position Summary
Our leading Biologics client based in Dublin is seeking to recruit a contract Senior Specialist, QA Compliance. Reporting to the Senior Manager, QA Compliance, the Senior Specialist, QA Compliance will support supplier quality operations for the Biologics Manufacturing site. This is a contract position until 31 Dec 2025
Key Responsibilities
• Release incoming materials for use in manufacturing operations
• Support qualification of new suppliers/materials and requalification of existing.
• Assess supplier change notifications for impact to qualification status.
• Support material certification and direct dispense programs.
• Review and approve quality agreements.
• Authoring, review and approval of QA-related procedures.
• QA review, assessment and approval activities for Biologics Manufacture, as applicable, for:
o Change controls
o Deviations/Investigations
o CAPAs
o Other associated documentation
• Support OpEx programs and champion continuous quality improvement initiatives.
Qualifications & Experience
* BSc in Science or related discipline with a minimum of 2 years’ Supplier Quality or related experience in a Biologics or Pharmaceutical environment.
* A clear understanding of cGMP requirements for QA systems and compliance and/or manufacturing.
* Detailed knowledge of Biologics Processing would be a distinct advantage.
Required to work on his/her own initiative in addition to working as part of a team. Excellent communication, presentation, time-management and organizational skills are essential.
* Employees are expected to display the Biopharma Behaviours, which enable them to be successful and perform at their highest level
Interested candidates should submit an updated CV.
Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up-to-date CV to audrey.mccarthy@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***
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