Fiona Hart

Experience

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  BioProducts Laboratory

  Jan 1984 - Jan 1994

  QA advisor

  • Manage routine raw material sampling and inspection activities.• Review and develop sampling & test procedures.• Manage calibration of critical test equipment.• Supervise & maintain a finished packaged product sampling and distribution system.• Validate autoclaves, heat treatment ovens and freeze drier.• Develop SOPs & Quality Standards documentation.• Supervise daily operation of the Sterile Suite and maintain the aseptic filling program.

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  GlaxoSmithKline

  Apr 2004 - now

  QA Manager

  • Performing batch documentation reviews and QP certification of IMP batches (multiple dosage forms) to meet EU GMP and approved CTA and Product Specification as required by Directive 2001/20/EC.• Providing direct support to the QA site lead in the management of the day-to-day aspects of the QA department – including deviation close-out and associated investigations, conducting Gemba and self-inspections, participating in Quality-based projects.• Leading, supporting, reviewing and timely approval of non-routine Quality investigations and Root Cause Analysis related to batch deviations, batch disposition, validation activities, stability results, customer and vendor complaints, OOS results and audit findings.• Pharmaceutical Quality System (PQS) – managing, maintaining and further improving a compliant documentation control system including policies, SOPs, batch manufacturing records, validation protocols and QC reports.• Leading or providing direct support during Third Party, internal ‘Audit & Assessment’ and Regulatory Agency inspections.• Leading or participating in self-inspections.• Providing support and advice on GMP and quality issues during cross-functional projects, investigations and day-to-day business activities. Show less