KAPIL DEV

• Versatile Job profile- Manager Project,Product & QMS
• Works as Project Manager - for new facility set up, expansion within the site ,Automation & simplification project from operation side.
• Set up Nutraceutical facility for Tablet capsule,Powder & Liquid dosage form.
• Project pertaining to facility setup,Automation & Quality compliance, Simplification,productivity & capacity enhancement & cost reduction etc.
• Create detailed project schedules and monitor progress to ensure projects stay on track.
• Monitor project progress and set deadlines.
• Manage the project budget & Evaluate project performance.
• Brief Project Description
• New Block addition to the facility for Tablets, capsule, protein powders & liquid dosage.
• Liquid section - Two manufacturing and two packing lines.
• Powder packing line.
• OSD Section – Granulation areas ,Compression, coating areas, Inspection, quarantines and day store areas.
• OSD section equipped with advanced machines 21 CFR compliant.
• Warehouse facility setup with separate cool and cold storage areas.
• New Facility setup especially designed for proteins powders.
• Works as Product Manager - For New Product Launch from start of the initiation of the project to commercialization.
• Ensure that projects are well defined, have clear objectives, and adhere to strict timelines and budgets.
• New product launch tracking through SNOP meeting among the stakeholder for ensuring the product launch on stipulated timeframe.
• The bridge gaps between different departments, ensuring everyone is aligned with project goals.
• Balance the demands of multiple projects and ensure that resources are used effectively.
• Coordinates across the company related to releasing new products to the market.
• Improved customer satisfaction ratings by ensuring prompt resolution of issues and concerns.
• Emphasis on the priority of customer satisfaction.
• Works as QMS manager
• Handling and managing QMS related activities [ Change control,Deviation, Incident, Market complaint, Audits etc.] of the department.
• Software exposure - Ample Logic, DMS etc.
• Handling & Managing - SOP's, BMR, BPR,Protocols, qualification documents URS,IQ,OQ & PQ etc.
• Additional works
• Oversee plant CAPEX,OPEX,REVEX,AOP & budgeting.
• Tracking of plant expenses and budgetary controls.
• Monthly plant presentations & business review meetings.
• Power point presentation and exhibition to the executives/clients.
• OEE monitoring and improving line efficiency.
• Plant expenses tracking and controls for minimization.
• Participation in the ESC program for sustainable tomorrow through act on environment protection, climate change, waste management, Rain water harvesting, Biodiversity and plantation.
• Participation in program for bringing certification “Great Place to work” to the organization.
• Motivation to the people for culture development, increasing efficiency through Reward & Recognition & best employee awards.
• GAMBA walk GAP assessment and improvisation the operations for enhancing the efficiency & productivity.
• Emphasis on the concept for productivity enhancement, cost saving, waste reduction, yield improvement, simplification and lean to bring profitability to the organization.
• Audit Faced- FSSAI, NSF GMP, ISO 14001:2015, ISO 45001:2018, FSSC 22000,TUV -SUD, Asia Pacific, SEDEX, Pharmacy poison board (Authority of Kenya), CDMO customer Audits [ GSK,BAYER, Sun PHARMA ,Dr.Reddy's, CIPLA, INTAS, IPCA, GLENMARK, ALKEM,TORRENT , ZYDUS,ABOTT,GLANBIA,HERBALIFE etc.

• Handling of day to operations of Manufacturing section [ Granulation, Compression & coating ].
• Shall follow daily, weekly and monthly production planning to achieve the plan as per set target.
• Effective utilization of plant resources.
• Carryout the activity in adherence with Batch record procedure,SOP, GXP compliance.
• Coordinate with cross functional dept. for smooth running of production activity.
• Took active participation in the training program.
• Filling the Formats/log- DPR/OEE, shift handover format allotted for the assessment of shift efficiency, shall report & discuss it with reporting manager/Designee.
• Adherence with the environment and Safety of the organization.
• Audit Faced - USFAD,MHARA, WHO GENEVA,TGA & EU GMP etc.

• Look after the manufacturing section [ Granulation,Compression,Coating ] day to day operations.
• Responsible for shop floor level implementation supervision and control of various activities of the downstream section and reporting of the events to the senior.
• Fill the batch record/format/logs etc. of respective area/section, review it after completion and timely submission to shift in-charge/Designee.
• Coordinate with cross functional dept. for smooth running of production activity.
• Training the down line operators & workmen to get the desired output.
• Adherence to the procedure of SOP ,Batch records & GMP perspective.
• Follow the health and safety procedures related to the job functions.
• Audit Faced _ WHO, EUGMP, KENEYA, TANZANIA etc.

• Oversee the manufacturing section operations of [ Granulation,Compression & coating ] under the supervision of senior staff.
• Filling up the batch record,logs and monitoring of the process.
• Follow daily, weekly and monthly production planning of respective area to achieve the plan as per set target.
• Performed online documentation activity in the section.
• Followed the hygienic & safe work operation adherence with the cGMP.
• Report to above reporting manager/Designee in case of failures,breakdown,incident etc. and track for its compliance.
• Handover the charge to next deputed designee.

Audit Faced- USFDA, TGA,MHRA ,ANISA etc.