Quality Operations Manager

2 days ago

Karachi, Sindh, Pakistan Pharmevo (Pvt.) Ltd Full time

Position: Quality Operation Manager (Karachi)

Job Specification

Qualification: B Pharm / Pharm D plus Degree in Management Sciences (MBA)

Experience: Minimum 5 years in a managerial position within an MNC or national pharmaceutical company

Job Description
  1. Supervise administrative activities of chemical & microbiological sections for raw material & finished product analysis & testing.
  2. Authorize release or rejection of incoming supplies, raw materials, or finished products.
  3. Oversee in-process testing of manufactured items.
  4. Review final microbial test reports.
  5. Monitor environmental conditions & advise on corrective actions in sterile areas.
  6. Follow up on development & evaluation of analytical methods & stability studies.
  7. Write/rewrite specifications, test methods, & other QC procedures including SOPs as necessary.
  8. Handle technical problems related to quality control.
  9. Ensure maintenance of department premises & equipment.
  10. Ensure validation processes, including analytical procedures & calibration of equipment, are completed.
  11. Manage availability of chemicals & glassware, and monitor personnel responsible for these tasks.
  12. Coordinate training programs for QC personnel.
  13. Ensure operational status of QC lab equipment & adequate space; liaise with service engineers for maintenance.
  14. Plan QC testing schedules in coordination with production planning.
  15. Participate in business/technical review meetings and implement action points.
  16. Manage administrative activities within the Quality Assurance section.
  17. Supervise release of finished products for the market.
  18. Handle customer complaints.
  19. Supervise vendor audits, internal audits, and facilitate customer audits.
  20. Oversee retention of reference samples & batch dossiers as per regulations.
  21. Supervise in-process checks during manufacturing.
  22. Perform any other duties assigned by superiors.
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