Manoj Kumar .
Manager at Saurav Chemicals Limited- Claim this Profile
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Bio
Experience
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Saurav Chemicals Limited
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India
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Manager
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Apr 2023 - Present
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Deputy Manager
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May 2022 - Present
Producing API’s and intermediates as per market requirement according to pre-approved procedure & instructions.Prepration & printing of BPR as per production Schedule.Prepration/updation of SOPs/documents related to production i.e.Validation,Qualication,product manual CPDR etc.Handling/ implementation/ evaluation of Change Control,CAPA,Deviations.Investigation of OOT,OOS &Deviations.Ensure all deviations reported, evaluated & investigated.Handling/impementaion/ updation of SAP related activities.Preparation of monthly reports and co-ordinate to other department.Supervision of PP Area operations &sampling activities.Ensure production facilities are cleaned & appropriate disinfected.Ensure necessary calibrations are performed & recorded as per schedule.Ensure equipments,facilities and area is appropriately qualified.Training of subordinates & compliance to learning programs as per schedule.Handling of training activity & it's compliance.Ensure dispatch/ transfer of finished API and intermediates as per schedule.Compliance to CQMS,SAP,BPR printing system.Compliance to cGMP,SOPs,EHS and HR policies.Compliance to audits and it's observations.Co-ordinate to all departments for smooth working.Handling of process /Powder Processing. Show less
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SUN PHARMA
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Pharmaceutical Manufacturing
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700 & Above Employee
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Worked
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Mar 2021 - May 2022
Producing API’s and intermediates as per market requirement according to pre-approved procedure & instructions. Prepration & printing of BPR as per production Schedule. Prepration/updation of SOPs/documents related to production i.e.Validation,Qualication,product manual CPDR etc. Handling/ implementation/ evaluation of Change Control,CAPA,Deviations. Investigation of OOT,OOS &Deviations. Ensure all deviations reported, evaluated & investigated. Handling/impementaion/ updation of SAP related activities. Preparation of monthly reports and co-ordinate to other department. Supervision of PP Area operations &sampling activities. Ensure production facilities are cleaned & appropriate disinfected. Ensure necessary calibrations are performed & recorded as per schedule. Ensure equipments,facilities and area is appropriately qualified. Training of subordinates & compliance to learning programs as per schedule. Handling of training activity & it's compliance. Ensure dispatch/ transfer of finished API and intermediates as per schedule. Compliance to CQMS,SAP,BPR printing system. Compliance to cGMP,SOPs,EHS and HR policies. Compliance to audits and it's observations. Co-ordinate to all departments for smooth working. Handling of process /Powder Processing. Show less
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Ipca Laboratories Limited
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India
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Pharmaceutical Manufacturing
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700 & Above Employee
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Worked
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Nov 2018 - Mar 2021
Producing API’s and intermediates as per market requirement according to pre-approved procedure & instructions. Working as a technical resource for operations personnel, applying technical skills to enhance plant production, to optimize plant operations, resolves plant problems, troubleshooting, revamping, debottlenecking to reduce time cycle and to produce product at low cost & superior quality. Responsible for handling of Deviation, OOT, OOS, CCP, TCCP, CAPA, QRA, Effectiveness check (EC) & finding Root Cause for maintaining Quality Management System (QMS) with TrackWise Software. Responsible for preparing daily/monthly production plan for all products. Responsible for preparing and sharing daily, weekly production reports. Responsible for maintaining discipline and harmony in plant. Responsible for smooth production and achieve required target with in time frame. Responsible for maintaining, recording and updating the documents related to the plant & production activities as per cGMP. Responsible for Qualification new, replaced or modified facilities and system/equipment’s. Responsible for self-inspection of the production area w.r.t EHS. Responsible for keeping control of water and utility consumption, effluent generation in plant. Responsible for controlling the hazardous waste generation and maintaining destruction record. Ensuring on line documents compliance as per the cGMP on daily basis for audit of plant. Providing need base training to plant personnel for cGMP, Safety & validation planning at plant levels. Preparing reports for Deviation, out of specification, out of trends, market complain and responsible for their compliance. Performing Quality Risk Assessment and Effectiveness Check of CAPA. Responsible for performing qualifications as URS and PQ of equipment’s/system/facility for prior to use in the process. Responsible for reporting of all production deviation and evaluation of the same. Show less
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MACLEODS PHARMACEUTICALS LTD.
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India
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Pharmaceutical Manufacturing
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700 & Above Employee
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worked
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May 2016 - Nov 2018
Responsible for the production activities Produced API’s and intermediates as per market demand. Reviewed all production batch records and ensured that these are completed and signed. Responsible for qualification of new and modified facilities and equipment’s. Responsible for maintaining and updating the documents related to the Production activities as cGMP. Safety compliance at plant level & ensuring safety environment at plant level. Looking of daily/shift production activities as per the production planning. On line documents compliance as per the cGMP requirements. Man & material management, & smooth production at plant level. Training of subordinates for critical activities & validation at plant levels. Maintaining of the documents required for day to day production activities. Carrying required qualifications like URS & PQ of all equipment’s prior to be used in the process. Ensuring on line GMP compliance of all documents on daily basis for audit of plant. Show less
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Nectar Lifesciences Limited
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Chandigarh Area, India
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Executive
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May 2009 - May 2016
sibilities: Hand on experience of operation continuous plant through PLC, SCADA and DCS system. Debottlenecking, revamping and optimization to increase plant capacity. Initiates changes to operating procedures to ensure they are valid and up to date. On line documents compliance as per the cGMP. Safety compliance at plant level & ensuring safety environment at plant level. Handled different solvents recovery & cost reduction project of different products. Man & material management for effective results. Training of subordinates for critical activities & validation at plant levels. Carry out qualifications as URS and PQ of all equipment’s prior to be used in the process. Erection and Commissioning of SCADA operated spray dryer other projects. Show less
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Surya Pharmaceutical Limited
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Chandigarh, India
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Project Engineer
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Feb 2008 - May 2009
Preparations of PFD, P&ID of different process. Performed Erection, Commissioning and Process calculation for products for bulk drugs. Performed conceptualization, basic & detailed engineering, equipment selection and sizing, heat and mass balance, PFD, P&ID, layout, piping drawings and related documentation. Coordinating the issues between other departments such as Civil, Electrical, Maintenance, Instruments, Quality Control, etc during the project execution. Performed Hydraulic calculations, Line sizing, Equipment sizing and selection. Preparation of Validation documents (URS, FAT, SAT, DQ, IQ, OQ, PQ) for different equipment’s/facility/system. Proficient in process engineering calculations & selection of process equipment’s. Actively involved in Erection and Commissioning of SCADA operated spray dryer. Introduced high, medium & low temperature utilities provisions as a temperature control for temperature sensitive reactions and drying operations etc. Resolved many problems of selection of material and equipment for particular solvents. Resolved lots of process, equipment’s issues & suggest perfect equipment’s hardware as per the process requirements. Show less
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Education
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C.R.State college of engineering murthal sonipat haryana
Bachelor of Engineering (B.E.), Chemical Engineering -
suvidya institute of technology Mumbai
Diploma in piping engineering, piping layout, stress analysis -
Govt. Polytechnic mandi adampur hissar haryana
Diploma, Food Processing -
Govt High School Rashina,Kaithal (HR)
10th -
National Fire Safety Management cillege Aurangabad
ADIS, Industrial Safety form MSBTE -
Maharastra state Board of technical Education
Advance Diploma In Industrial Safety (ADIS), Industrial Safety