LSC requires a Senior Plant QA Associate for a South Dublin based Biopharmaceutical Company that specialises in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
The Plant Quality Assurance (PQA) Snr Associate will typically report to a QA Manager and is a core member of the site Quality Assurance team. The PQA Snr Associate will serve as Quality point of contact for manufacturing operations.
A variety of shift patterns may be required to support manufacturing operations, including but not limited to day shift, 16/5 shift, 24/5 shift and 24/7 shift. Weekend work may also be required.
-Perform all activities in compliance with company safety standards and SOPs
-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, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
-Participates in customer complaint investigations.
-Provides 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, including observation and provision of direction during media fills and assessment of aseptic interventions.
-Perform Visual Inspection AQL inspections and provide quality oversight for the inspection program
-Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
-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
-Any other tasks/projects assigned as per manager’s request.
Education and Qualifiactions:
-University degree. Engineering or Science related discipline preferred.
-Relevant experience (4 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.
For further details please call Evelyn at LSC on 021 4777329 or apply with your CV directly through this advert.