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Job Description
Key responsibility
- Develop and implement comprehensive calibration procedures for laboratory instruments, production equipment, and utility critical activities.
- Create and manage Calibration Management Plans (CMP).
- Perform complex calibration, adjustment, and maintenance tasks.
- Analyze, interpret, and review raw data obtained during verification and calibration activities.
- Prepare and follow up on detailed calibration reports.
- Manage third-party calibration services and ensure their compliance with internal and regulatory standards.
- Provide technical assessment of change controls, deviations, and CAPAs related to the processes developed in GEPD.
- Ensure compliance with regulatory requirements and internal quality standards.
- Lead and mentor a small team of calibration technicians, providing training, guidance, and performance evaluations.
- Foster a collaborative and high-performance team environment.
Job Requirements
Academic experience required
- Bachelor's degree on Engineering or Health-related Sciences.
- Knowledge of current Good Manufacturing Practices (cGMP).
Professional Experience Required
- Typically requires 2 to 5 years of calibration experience in the pharmaceutical industry under cGMP.
- Over 5 years of professional experience leading teams.
Computing Skills
- Knowledge of Microsoft Office applications.
- Knowledge in using maintenance management software systems (SAP PM or similar)
