Packaging Manager

Control manufacturing activities in the respective section to ensure activities carried out are as per requirement of cGMP & safety to meet the quality and packaging targets in time. Key Accountabilities:Monitor and control planned production by daily activity review as per packaging plan to meet packaging targets and quality standardsReview planned production vs. actual production daily and control the production activity of the plant as per the schedulePrepare production schedules for the block and ensure adherence to the schedulesEnsure availability of raw materials, reagents and solvents during all shifts by verifying it with the forecastsEnsure execution of new product & product transfer by performing gap analysis to meet market requirementsReview in-process analysis on daily basis to enhance the quality of final productMonitor unit operations and processes to avoid failuresEnsure seamless communication and knowledge transfer of product in line across shifts for continuous production by participating in shift performance dialogueEnsure maintenance is carried out as per standards to realize optimum utilization of manufacturing consumablesClose maintenance issues by reviewing processes to meet production targets by coordinating with EngineeringOptimize the utilization of packaging consumables as per the budgets to reduce overhead costConduct 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 breakdownPrepare, review and update GMP documents to meet regulatory compliance and quality of productPrepare the facility and rectify issues related to facility management and documentation for audit readinessHandle investigations, OOS, OOT, change controls, deviation & CAPA in the blockEnsure online documentation for any non-conformance to meet GMP by performing surprise checksPrepare and review the qualification, validation and other documents to maintain GMPParticipate in the internal and external audits to assure system controlReview new batch manufacturing records, SOPs, APQR for correctness and completeness and provide recommendationsEnsure adequate and trained manpower availability across shifts to ensure production continuityEnsure effective utilization of manpower in each shift by understanding workload and requirement to get desired production outputPlan and impart training on SOPs, new guidelines and policies to for achieve zero non-conformanceMonitor employee and workplace safety to maintain safe environmentEnsure all operations are performed as per safety norms to avoid accidents in plantEnsure availability and maintenance of PPEs by coordinating with HSE department for requirements and shift scheduleConduct safety training by coordinating with HSE to promote a culture of safe workingImplement packaging excellence practices for continuous improvementEnsure maximum utilization of the machine in a shift by reviewing reports during shift performance dialogueReview the OOE data and monitor the PDCA system to minimize the lossesTrack monthly change over time of machine to sustain the baselinePrepare the plans for utilization of bottleneck machines to reduce the time lossMonitor the yield of runner products to ensure yield above baseline Education and Experience:Bachelor’s degree, or education in pharmaceutical manufacturing, industrial management or related field of study from an accredited college/university is preferred.Minimum of five to nine (5-9) years’ experience in formulation manufacturing with understanding of manufacturing procedures, cGMP and systems related documentation in a cGMP pharmaceutical operation environment.