Senior Quality Assurance Specialist
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Ireland's leading biotech company are now expanding their Quality Team are are looking for a Senior Quality Assurance Specialist to join their team at their growing site in Raheen, Co Limerick. This site is in production at the moment and when finished, it will be the largest-scale bulk-biologics production facility in Europe. This is an amazing time to join!
The Role
The Senior Quality Assurance Specialist performs and leads activities in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement Documents.
* Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
* Represents the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications
* Review and approve investigations associated with raw materials, product, laboratory, or facilities
* Perform activities associated with disposition of raw materials and product (e.g. manufacturing record review, receipt, inspection, document review, shipping, etc). Activities may be on the floor or at a desk
* Continually evaluating processes and procedures with an eye toward continuous improvement
The Candidate
The successful Senior Quality Assurance Specialist will be an ambitious individual that is excited by the prospect of working in a start-up environment. They will have excellent Quality Assurance experience in either the Pharmaceutical or Biotech industry. They will enjoyed being challenged in their role.
Education and Experience
Requires BS/BA in scientific discipline
Minimum 5 year relevant experience.
Understanding of biologics manufacturing operations is preferred
Not sure yet? No CV ready? Give me a call on 01-8883477 for more information
SThree UK and Ireland is acting as an Employment Agency in relation to this vacancy.
