Section Head - Production

Mfg. Section Head

Control manufacturing activities in the respective section to ensure activities carried out are as per requirement of cGMP & safety to meet the quality and manufacturing targets in time.

Key Accountabilities:

• 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

Major Challenges:

• Meeting priority demands during clashing equipment requirement in multiproduct facility
• Keeping up with production schedule during facility renovation and equipment upgrade
• Utilisation of capacity as per the production plan due to volatile demand
• More lead time for approval of regulatory documents by internal and external stakeholder
• Unavailability of machine spares items because of limited budget
• Long cycle time for variation approval or modification in batch manufacturing record due to delayed response by internal stake holder i.e. RA, R&D, LCM team and CQA
• Issues in Quality of Raw Material i.e. lumps formation, presence of foreign material etc.

Key Interactions:

• Internal:
  Quality Assurance/Control for scheduling…