Ensure the compliance of shop floor.
Safety
To ensure 100% safe operation in production area, follow SOPs, proper earthing, additional precautions for solvent, people to know firefighting training and use of fire extinguisher.
Ensure all the necessary PPE’s are available in production facility and monitor proper PPE’s are worn by the personnel’s during manufacturing and packaging operation.
Reporting the near misses and ensure their compliances.
Own and team involvement in safety committee meeting and activities should 100%.
Implementation of Environmental monitoring system in production area.
Conduct and participate in Environmental monitoring system internal audit and process.
Ensure the handling of waste material as per SOP.
Quality and Compliance
No critical/major observations in GMP regulatory audit i.e. internal/external.
cGMP Compliance in entire manufacturing area and SOP compliance on all aspects.
Up gradation of system consistently to deliver the quality production, improvement to plan.
Check all areas log books, BMR entries and all documents calibration records are online and updated.
Zero Line clearance failures and cross contamination.
To ensure 100% adherence to the SOP/Batch instructions, specifications and control parameters
Zero overdue on Training requirements CAPA in executed state
Ensure no major/critical market complaints, incidents do Gemba walk.
Follow ALCOA and ready for any time inspection.
To Follow the Good documentation practice, cGMP compliance and regulatory compliance.
Execution of the documentation as per SOP and regulatory requirement.
Review and compliance of Batch manufacturing record in stage wise.
Delivery:
To review the Production planning, weekly / monthly / yearly as per the forecast /market requirement and complete within timelines.
Ensure day to day, weekly and monthly target adherence to achieve on time delivery / dispatch.
Monitoring and evaluation of daily/ weekly/ monthly report and micro planning to achieve the target i.e. plan vs. actual NLT 95%.
To maintain machine, area and accessories with minimum breakdown. PMP and spares management.
Shift utilization must be maximum, target for 400 minutes machine operation.
Pre checks and arrangement of all process related equipment’s to minimize delay.
Supporting Manufacturing Projects
Supporting culture of excellence.