Section Head - Production

Section Head - Production

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.

• Monitor and control planned production by daily activity review as per production plan to meet production targets and quality standards.
• Review planned production versus 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 a 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 achieve zero non‑conformance.
• Monitor employee and workplace safety to maintain a 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 practices for continuous improvement.
• Ensure maximum utilisation of the machine in a shift by reviewing reports during shift performance dialogue.
• Review the OOE data and monitor the PDCA system to minimise the losses.
• Track monthly change over time of machine to sustain the baseline.
• Prepare the plans for utilisation of bottleneck machines to reduce the time loss.
• Monitor the yield of runner products to ensure yield above baseline.

• Meeting priority demands during clashing equipment requirement in multiproduct facility – Overcome by efficient planning.
• Keeping up with production schedule during facility renovation and equipment upgrade.
• Utilisation of capacity as per the production plan due to volatile demand – Overcome by rescheduling of plans.
• More lead time for approval of regulatory documents by internal and external stakeholder – Overcome by regular follow ups.
• Unavailability of machine spares items because of limited budget – Overcome by maintaining the centralised control system for minimum stock of spare to be maintained at stores for all identified machines.
• Long cycle time for…