Associate, QA

1 week ago

Paranaque City, Calabarzon, Philippines Zuellig Pharma Full time

Responsible for conducting call quality audits and documentations check to verify compliance with Patient Solution operations procedures.

  • QA
  • Responsible in ensuring compliance with Quality Management System to meet quality standards, and support achievement of quality objectives.
  • Ensure compliance with the Patient Care and program Standard Operating Procedure.
  • Responsible for conducting call quality audit to the Patient Care Consultants
  • Perform call quality calibration with the team supervisor and operations manager, trending call quality parameters.
  • Responsible for Documentation audit by performing spot checks to evaluate source data comprehensiveness and accuracy
  • Responsible in ensuring complete documentation to the system of the Patient Care Consultant by comparing it with the call recording summary
  • Ensures compliance with Patient Care and Client Pharmacovigilance procedure
  • Ensure that if there is a missed AE to inform immediately the Patient Care Consultant and supervisor/manager for it to be reported within the agreed timeline.
  • Attends to internal / external or Client audits.
  • Prepares management reports and performs data analysis.
  • Conducts regular trainings to Patient Care Consultants and Navigators
  • DOCUMENT CONTROLLER
  • Responsible for reviewing and routing ISPI documents and forms to the eQMS
  • Ensure that the program-specific Standard Operating Procedures are reviewed before due.
  • Regularly updating the Masterfile and SharePoint
  • REGULATORY AND PROGRAM SUPPORT
  • Perform other job functions as may be required from time to time or as may be necessary in support of program objectives.
  • Back-up in the absence of Regulatory Affairs Associate
  • Reviews the PV SOP and conducts PV training
  • Acts as back up in the review and approval of MDRF on updating customer's LTO
  • Keeps abreast of new regulations and industry practices.

Bachelor's degree in pharmacy

Registered Pharmacist

Min. 2+ years of experience in hospital setting or equivalent

Min. 2+ years of experience in Quality Assurance or equivalent

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