· Implementation of quality assurance standards, processes, controls and cGMP in the warehouse.
· Conducting training for employees on SOPs, GMP and GDP.
· To ensure all time compliance to Regulatory, ISO and WHO GSDP requirements.
· Handling of Incidence Reports, Complaints, Deviations and Change controls as per respective SOP.
· To investigate the incidence / deviation / complaint and ensure effectiveness of CAPA.
· Maintaining documents and reports as per respective SOPs.
· Monitoring the cleanliness and pest control activities within the warehouse.
· Monitoring the temperature in the storage area and maintain its record.
· Verification of Eurotherm Alarm System, and investigation of critical alarm as defined in SOP.
· Monitoring of calibration schedules, validation schedules and preventive maintenance schedules.
· To review Qualification and Validation documents.
· Review of all GMP documents such as, Incidence, Deviation, Change control, CAPA, Risk Assessment etc. for closure and completeness.
· To participate in internal and external audits and provide the required response.
· To perform the internal audits and provide the required response to the team.
· To prepare weekly and monthly report and shall provide to senior management.
· To escalate any matter related to quality impact to the respective person / senior management.
To communicate with Principal Company QA for any matter related to Quality.
To execute any other assignment allocated by Head Quality.