Qualification

 

  • Responsible for the qualification / validation studies required to support the introduction of new manufacturing, filling and packaging processes as well as the monitoring / re-qualification of existing processes and challenging integrated lines.
  • Generate list of prerequisites required prior to initiating process qualification / validation activities.
  • Generate protocols, technical memos, feasibility / development studies, sampling plans, acceptance criteria, and final reports.
  • Support the generation of defect inspection criteria and AQL based sampling plans.
  • Develop qualification / validation rationales for requirement of number of challenge runs, bracketing, matrix, and critical process / product parameters.
  • Communicate status of prerequisites, open items, deviations, execution activities and project timelines.
  • Collect and tabulate laboratory data, review laboratory data for errors and discrepancies, and transcribe results into final reports.
  • Generate, review and approve validation procedures.
  • Generate final reports, compile historical data packages, preform statistical evaluation, generate discussion of results and scientific based conclusions, and route documents for approval.
  • Generate and maintain a site process qualification / validation program plan.
  • Review and approve interventions and assess product impact / potential product risk as the result of atypical interventions.