Overview
Calibration Officer Jobs in Sungai Petani, Kedah, Malaysia at SUN PHARMA
Title: Calibration Officer
Company: SUN PHARMA
Location: Sungai Petani, Kedah, Malaysia
Job Purpose
To ensure accurate, reliable, and compliant calibration of instruments and measuring devices used in pharmaceutical manufacturing, in accordance with GMP, regulatory requirements, and data integrity principles.
Key Responsibilities
1. Calibration Execution
– Coordinate with external calibration agencies
– Monitor calibration of temperature, pressure, flow, level, and humidity instruments, DP gauges and control devices.
– Ensure traceability to national/international standards
–
2. Calibration Planning & Scheduling
– Prepare and maintain calibration schedule
– Ensure timely completion of calibrations
– Manage instrument status identification (calibrated, due, under maintenance)
3. Documentation & Compliance
– Maintain GMP-compliant calibration records
– Ensure data integrity (ALCOA+)
– Prepare SOPs, calibration reports and review calibration certificates on time.
– Handle deviations, investigations, and CAPA
4. Instrument Management
– Maintain master instrument list and database
– Evaluate instrument performance
– Ensure proper tagging and identification
5. Audit & Regulatory Compliance
– Support internal/external audits
– Address audit observations and CAPA
– Ensure compliance with GMP and NPRA standard.
6. Troubleshooting & Technical Support
– Troubleshoot calibration failures
– Support production and QA teams
– Minimize downtime during calibration activities
7. Vendor Coordination
– Coordinate with NABL/ISO accredited labs
– Review vendor calibration certificates
– Ensure vendor compliance
Qualifications & Experience
– Degree/Diploma in Instrumentation/Electrical/Electronics
– 2–6 years in pharmaceutical / medical devise industries
– GMP experience mandatory
Technical Skills
– Calibration techniques and standards
– Process instruments and sensors
– Basic PLC/SCADA knowledge
– Familiarity with CMMS/SAP
– Knowledge of ALCOA+ and ISO 17025 (preferred)
