Global Biotechnology company based in south Dublin, Ireland - looking for Senior QA Associate.
The PQA Snr Associate will serve as Quality point of contact for manufacturing operations. This is a 24/7 shift role required to support manufacturing operations.
The role:
* Perform all activities in compliance with safety standards and SOP's.
* Write, review and approve Standard Operating Procedures in accordance with Policies.
* Provide Quality support for triage and investigation of all classes of non-conformance (NC) events.
* Review and approval of deviations for closure ensuring compliance with appropriate documentation.
* Participates in customer complaint investigations.
* Observe and provide real-time quality oversight, and support for production unit operations, extending to formulation, vial and Syringe Fill Finish related activities, including observation and provision of direction during media fills and assessment of aseptic interventions.
* Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
* Review and approve cGMP records ensuring compliance with appropriate documentation.
Have You:
* University degree. Engineering or Science related discipline preferred.
* Relevant experience (3 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
* Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations.
* Experience working in aseptic operations, protein formulation, vial and syringe filling.
* Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.
The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.
Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-group.com
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to akremenskas@berkley-group.com
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance
* Pharmaceutical Manufacturing
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