QA Associate - Dublin
CK Group are recruiting for a Senior Quality Assurance Associate to join a pioneering biotechnology company that have helped develop and deliver innovative therapeutics to patients worldwide to fight against serious illnesses. The QA Associate will be employed on a 12 month contract at the manufacturing site located near Dublin.
The successful QA Associate will be required to:
- Write, review and approve Standard Operating Procedures in accordance with company policies.
- Provide Quality support for triage and investigation of all classes of non-conformance (NC) events
- Review and approval of NC1s and CAPAs for closure ensuring compliance with appropriate documentation
- Address root cause issues and ensure implementation plans are in place
- Participate in customer complaint investigations.
- Provide training and advice to staff in order for them to perform their desired functions.
- Observe and provide real-time quality oversight, and support for production unit operations, extending to formulation, vial and Syringe Fill Finish related activities
- Perform Visual Inspections and provide quality oversight for the inspection program
- Review/approve production batch records, and associated documentation
- Review and approve cGMP records (e.g., NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
- Support continuous improvement and Operational Excellence initiatives
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- The successful candidate will have a degree or equivalent qualification in a Science or Engineering related discipline
- Significant experience gained within the pharmaceutical or biotechnology industry would be preferable.
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
- Experience working in aseptic operations, protein formulation, vial and syringe filling.
For more information or to apply for this position, please contact Julie Marshall on 01438 723500 email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ST40338 in all correspondence.