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Job Description
Accountability Cluster
Major Activities / Tasks
- Monitor and control planned production by daily activity review as per production plan to meet production targets and quality standards
- Review planned production vs. actual production daily and control the production activity of the plant as per the schedule
- Prepare production schedules for the block and ensure adherence to the schedules
- Ensure availability of raw materials, reagents and solvents during all shifts by verifying it with the forecasts
- Ensure execution of new product & product transfer by performing gap analysis to meet market requirements
- Review in-process analysis on daily basis to enhance the quality of final product
- Monitor unit operations and processes to avoid failures
- Ensure seamless communication and knowledge transfer of product in line across shifts for continuous production by participating in shift performance dialogue
- Ensure maintenance is carried out as per standards to realise optimum utilisation of manufacturing consumables
- Close maintenance issues by reviewing processes to meet production targets by coordinating with Engineering
- Optimise the utilisation of manufacturing consumables as per the budgets to reduce overhead cost
- Conduct the daily cross functional AET meeting to continuously improve Yield, Solvent recovery, reduce OOS, OOT and complaints.
- Evaluate the requirement and ensure the availability of critical spare and consumables for the machines to avoid time loss during any machine breakdown
- Prepare, review and update GMP documents to meet regulatory compliance and quality of product
- Prepare the facility and rectify issues related to facility management and documentation for audit readiness
- Handle investigations, OOS, OOT, change controls, deviation & CAPA in the block
- Ensure online documentation for any non-conformance to meet GMP by performing surprise checks
- Prepare and review the qualification, validation and other documents to maintain GMP
- Participate in the internal and external audits to assure system control
- Review new batch manufacturing records, SOPs, APQR for correctness and completeness and provide recommendations
- Ensure adequate and trained manpower availability across shifts to ensure production continuity
- Ensure effective utilisation of manpower in each shift by understanding workload and requirement to get desired production output
- Plan and impart training on SOPs, new guidelines and policies to for achieve zero non-conformance
- Monitor employee and workplace safety to maintain safe environment
- Ensure all operations are performed as per safety norms to avoid accidents in plant
- Ensure availability and maintenance of PPEs by coordinating with HSE department for requirements and shift schedule
- Conduct safety training by coordinating with HSE to promote a culture of safe working
- Implement manufacturing excellence practises for continuous improvement
- Ensure maximum utilization of the machine in a shift by reviewing reports during shift performance dialogue
- Review the OOE data and monitor the PDCA system to minimize the losses
- Track monthly change over time of machine to sustain the baseline
- Prepare the plans for utilization of bottleneck machines to reduce the time loss
- Monitor the yield of runner products to ensure yield above baseline
