Be a leader in introducing and coordinating improvements through training, coaching, new quality tool implementation, authoring/editing standard operating procedures, and owning Capas, where appropriate.

More Uses of the Capas Toolkit:

  • Support technical direction for process related deviations, Capas and change controls.
  • Evaluate: own or support identified internal Capas and manage to timely root cause investigation, implementation and closure.
  • Assure your organization provides administrative support through creation of Corrective and Preventive Action (Capas), tracking of finding resolution, and reporting audit metrics.
  • Orchestrate: work as a member of a cross functional team to drive root cause analysis and Capas.
  • Assure your operation tracks and monitors internal process nonconformities, deviations, complaints, and Capas to drive closure.
  • Ensure you carry out; lead/support cross functional teams to resolve quality issues and complete Capas.
  • Guide: GCP quality assurance, Capas, deviations, audits, sops.
  • Lead Capas to solve manufacturing problems, account for process deviations, and change control processes.
  • Ensure accurate and timely maintenance and review of manufacturing investigations, Capas, change controls and complaints.
  • Support quality systems activities as ownership of Capas, customer complaints, audit finding, etc.
  • Investigate and resolve exceptions, nonconformances, deviations, Capas, and change controls related to Validation protocols.
  • Engage in internal/external Capas, improvement, and design change opportunities.
  • Systematize: monitor and track and trend deviations, Capas, change controls to ensure proper documentation, timely closure, and suitable steps identified to prevent recurrence.
  • Resolve manufacturing issues along with daily review of manufacturing investigations, change controls, complaints, and Capas.
  • Develop, write, approve, implement, and monitor effectiveness of Capas.
  • Confirm your group complies; deviations, Capas), operational data as part of the manufacturing lifecycle, and financial data (e.
  • Take the lead in ensuring that deviations, Capas, and change controls issued to your organization are properly tracked, closed on time, or extended if necessary.
  • Confirm your organization complies; effectiveness checks are performed to ensure ongoing compliance with the implemented Capas.
  • Secure that your group writes issue reports for equipment and facilities related deviations and Capas.
  • Verify the timely completion of Capas by means of routine contact with the supplier.
  • Provide quality assurance support to software related Capas.
  • Ensure you helm; lead/lead post market risk management review with cross functional teams to assure risks are minimized and potential Capas are initiated.
  • Ensure you enforce; lead the resolution of quality issues related to non conformance reports and Capas.
  • Support quality assurance with audits, Capas, change control, deviations, root cause analysis, and complaint handling.
  • Confirm your corporation ensures compliance activities ( as Capas) are appropriately resourced and managed.
  • Assure your design complies; projects stemming from Capas, training deficiencies, and general procedural improvements.

 

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