Responsibility

Handling of Incidents, OOS, OOT, OOC, deviations and change control in Quality Control Department.
Implementation of CAPA related to QMS to all Quality Control laboratory.
To provide training related to QMS to all QC personals.
Preparation of trends data for OOS, OOT and incidents in Quality Control.
To prepare and review investigation of QC and other departments as CFT member.
To ensure all analysts are trained and qualified in required analytical test methods/techniques.
To ensure submission of stability data to QA/ RA for registration of drug products to different regulatory bodies.
To prepare and review SOPs, STPs, Specifications, GTP and Protocols of Quality Control Department.
To ensure Internal and External Calibration/ Validation, Temperature Mapping of Instrument and Equipment of Quality Control Department.
Responsible for Preventive Maintenance, Calibration and Qualification of instrument and equipment of Quality Control Department.
To coordinate with outside testing laboratories or inter location laboratories.
Ensure that all analysts understand and follow current good laboratory practices.
To coordinate with external vendor for procurement of QC requirements.
To arrange internal and external training for QC persons to improve knowledge and work efficiency
Monitoring temperature and relative humidity of stability chambers as per approved procedures.
Responsible for GLP section such as planning and execution of in-house working standards, handling and usage of HPLC/ GC columns, chemical management.