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QA Senior Specialist

Job description

Job Responsibilities;

  • As the QA Senior Specialist you will perform write, review and approve Standard Operating Procedures in accordance with Policies as well as 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.
  • 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.

Job Requirements;

  • The QA Senior Specialist will have a BSc or BEng in a related discipline with 4 years relevant pharmacetuical/ biotechnology expereince.
  • They will have demonstrated abillity in porblem solving and experience in the managment of investigating deviations and 
  • 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.

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