Section Head of QC

1 week ago

Kaliwungu Central Java, Indonesia PT Adventa Biotech International Full time

Job Description

  1. Review the preparation of protocols and qualification, validation, and calibration reports, as well as deviation reports, and monitor deviation report logsheets.
  2. Review the preparation of deviation reports in terms of qualification, validation, and calibration.
  3. Review change control submissions in terms of qualification changes, calibration changes, and validation changes.
  4. Review risk analysis submissions in terms of qualification, validation, and calibration.
  5. Coordinate the validation, qualification, and calibration processes with the Validation Team, Qualification Team, and Calibration Team.
  6. Review all data trends created by Incoming QC, Outgoing QC, QC Lab, and IPC Staff.
  7. Conduct/coordinate internal and external audits together with the auditor team.
  8. Conduct/coordinate internal/external personnel training for the Quality Control Department. Ensure that personnel training for all departments is carried out in accordance with applicable procedures.
  9. Report all work to the Quality Manager.

Job Qualifications

  1. Minimum bachelor's degree. Preferably in Pharmacy and Engineering.
  2. Minimum 3 years of experience in the Quality Control Department/Production Department of the Pharmaceutical and Medical Device Industry as a Supervisor.
  3. Knowledge of Good Medical Device Manufacturing Practices (CPAKB), Halal Assurance System (SJH), and ISO 13485.
  4. Good presentation skills, analytical skills, and team coordination skills.
  5. Honest, decisive, and able to work under pressure.
  6. Possess skills in instrument calibration, machine qualification, and validation processes.
  7. Minimum proficiency in Microsoft Office programs and statistical analysis.

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