QA Supervisor (11 am - 7:30 pm)

SUMMARY:
Under limited supervision and guidance of the SR. QA Manager is responsible for the following duties:

ESSENTIAL FUNCTIONS:
Include the following. Other duties may be assigned.

  1. Coordinates daily QA activities to support Production and QC departments.
  2. Responsible for Weekly Metrics of Raw Materials and Components releases.
  3. Facilitate and coordinate Equipment cleaning verification prior to Production use.
  4. Coordinate Weekly staff meetings with QA Techs.
  5. Responsible for coaching, mentoring, providing feedbacks to QA Techs and Production operators. Coach Junior Staff.
  6. Perform employee yearly reviews.
  7. Acts a Liaison with ACM Staff and Production Staff
  8. Facilitate and Coordinate Triages on the Shop floor to promote alignment with other departments.
  9. Provide Shift Change reports.
  10. Provide/Support/Assist with Metrics as per Management requests.
  11. Review of Batch Records and any Ancillary GXP documents executed during Production.
  12. Initiate non-conformances and complete CAPA’s and effectiveness checks.
  13. Successfully meet Aseptic gowning qualifications.
  14. Facilitate/coordinate stability samples for finished product.
  15. Facilitates Process Improvements.
  16. Raw Material COA review and release.
  17. Responsible for Shop Floor QA program
  18. Responsible to facilitate Change controls/DCR’s execution.
  19. Responsible for developing Training plan for Junior Staff/new employee.
  20. Responsible to Coordinate and facilitate Production coverage/support.
  21. Inspection and evaluation of incoming packaging and labeling components.
  22. Perform Line Clearances.
  23. Physical evaluation of drug products such as but not limited to: Torque test, leakage, fill weight, etc).
  24. In-process inspection of drug products during filling and packaging operation for correct product strength, lot, expiration date, etc.
  25. Collecting and testing cleaning samples and assisting with cleaning validations.
  26. Recording room pressure and temperature data (aseptic core).
  27. Monitoring purified water system for temperature, pressure, resistivity, etc.
  28. Verifying the raw materials/ incoming components are in the right status in JDE and physical location
Publicado hace 3 días
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