Job Description
- Review the preparation of protocols and qualification, validation, and calibration reports, as well as deviation reports, and monitor deviation report logsheets.
- Review the preparation of deviation reports in terms of qualification, validation, and calibration.
- Review change control submissions in terms of qualification changes, calibration changes, and validation changes.
- Review risk analysis submissions in terms of qualification, validation, and calibration.
- Coordinate the validation, qualification, and calibration processes with the Validation Team, Qualification Team, and Calibration Team.
- Review all data trends created by Incoming QC, Outgoing QC, QC Lab, and IPC Staff.
- Conduct/coordinate internal and external audits together with the auditor team.
- 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.
- Report all work to the Quality Manager.
Job Qualifications
- Minimum bachelor's degree. Preferably in Pharmacy and Engineering.
- Minimum 3 years of experience in the Quality Control Department/Production Department of the Pharmaceutical and Medical Device Industry as a Supervisor.
- Knowledge of Good Medical Device Manufacturing Practices (CPAKB), Halal Assurance System (SJH), and ISO 13485.
- Good presentation skills, analytical skills, and team coordination skills.
- Honest, decisive, and able to work under pressure.
- Possess skills in instrument calibration, machine qualification, and validation processes.
- Minimum proficiency in Microsoft Office programs and statistical analysis.