Job Description:
· Implementation of quality assurance standards, processes, controls and cGMP in warehouse & redressing activity.
· Conducting training for employees on SOPs, GMP and GDP.
· To ensure all time compliance to regulatory, ISO and WHO GSDP requirement.
· Handling of incidence reports, complaints, deviation 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 schedule, validation schedule and preventive maintenance schedules.
· Supervision of Cold chain packing.
· To review SOPs and ensure their proper implementation.
· To be part of Risk Assessment team.
· To review Qualification and validation documents.
· Review of all GMP documents such as, incidence, Deviation, Change Control, CAPA, etc, for closure and completeness.
· To participate in internal and external audits and provide the required response.
· 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 customer QA for any matter related to quality
· To execute any other assignment allocated by Head Quality.