Vikash Kiroriwal
Hisar
Summary
Aspiring for assignments in Pharmaceutical sterile formulation Production/ Manufacturing with leading organization of repute in Pharmaceutical industry.
Dynamic professional with over 9-years’ Experience in Injectable Production (SVP) Liquid, Dry powder and Lyophilization formulation. Functional Expertise in handling the Production Operations with key focus on regulatory requirement and profitability by ensuring optimal utilization of resources. Experience in delegating work schedule, preparing SOP’s, protocols and proficient in implementing audit compliance on shop floor as per cGMP requirement. A result oriented professional and effective leader deft in creating and sustaining dynamic environment that foster the development opportunities and motivate the high performance amongst the team member. A good communicator and the ability to work in a cross-functional team.
Overview
17
17
years of professional experience
Work History
Team Leader – Production
DR. Reddy’s Laboratories Ltd.
Baddi
05.2021 - Current
- Leading and executing shift activities like washing & depyrogenation, sterilization aseptic filling and Lyophilization
- Sterile area maintaining, monitoring and up keeping the area as per the cGMP and regulatory requirements
- To prepare and submit all daily reports such as DPR, WIP etc
- And periodical reports covering different aspects of production such as GMP Inspection of Equipment, Change Parts
- Production participant during autoclave, tunnel, Lyophilizer, vial washing machine, EDMC and area Qualification
- Responsible for planning and execution of Process simulation in sterile formulation (Media fill)
- One of certified trainer of production department to evaluation and monitoring of immediate subordinates
- To complete all QMS element on time such as Log Books Review, Event, incident, change control and CAPA
- To ensure a lean and clean shop floor by monitoring material issuance from warehouse & maintaining the stocks of miscellaneous, consumables required for production
- Maintenance of GMP records for production area & reviewing BMR & other document
- Actively involved in compliance activity regarding departmental Issue
- Procurement of machine parts, spare part and assures the availability of accessories
- Management of glove port glove such as cleaning, inspection, integrity, sterilization
- Responsible for new and scheduled Production personnel gowning Qualification, aseptic area operator Qualification
- Reviewing of CCTV footage online, during BMR review and as per Footage reviewing frequencies
Senior Executive – Production
Mylan Laboratories Limited
Bangalore
10.2015 - 04.2021
- Leading and executing shift activities like washing & depyrogenation, sterilization aseptic filling and Lyophilization
- Sterile area maintaining, monitoring and up keeping the area as per the cGMP and regulatory requirements
- To prepare and submit all daily reports such as DPR, WIP etc
- And periodical reports covering different aspects of production such as GMP Inspection of Equipment, Change Parts
- Production participant during autoclave, tunnel, Lyophilizer, vial washing machine, EDMC and area Qualification
- Responsible for planning and execution of Process simulation in sterile formulation (Media fill)
- One of certified trainer of production department to evaluation and monitoring of immediate subordinates
- To complete all QMS element on time such as Log Books Review, Event, incident, change control and CAPA
- To ensure a lean and clean shop floor by monitoring material issuance from warehouse & maintaining the stocks of miscellaneous, consumables required for production
- Maintenance of GMP records for production area & reviewing BMR & other document
- Actively involved in compliance activity regarding departmental Issue
- Procurement of machine parts, spare part and assures the availability of accessories
- Management of glove port glove such as cleaning, inspection, integrity, sterilization
- Responsible for new and scheduled Production personnel gowning Qualification, aseptic area operator Qualification
- Reviewing of CCTV footage online, during BMR review and as per Footage reviewing frequencies
Executive- Production
Nectar Life Science Limited
Baddi
04.2013 - 09.2015
- Planning and execution of daily and monthly scheduled production targets
- Responsible to handle all manufacturing activities on shop floor as per regulatory requirement
- Team member as SME in internal & external inspections like WHO, cGMP, Uganda, Nigeria, Eu GMP and USFDA
- Daily recording of DPR, WIP and break down related issues
- To handle the team to achieve the set targets and maintaining qualitative, quantities as well as cGMP aspect
- Co-ordination with F&D, Engineering, and QA, QC for optimization and validation batches for upcoming products
- Involved in protocol preparation for trial, Machine Qualification, creation and updating of SOP’s etc
- Execution of Media Fill Operation, process validation
- Validation Representative from production during autoclave, tunnel, vial washing machine validation
- Preparing the daily, weekly and monthly report and react accordingly to achieve targets
- Manpower allocation and utilization accordingly to their Skill
- Troubleshooting and Supporting Production without GMP impact
Executive – Production
Ind Swift Limited
Parwanoo
11.2010 - 03.2013
- Handled activities like dispensing, washing & depyrogenation, sterilization, filling and optical inspection of vials
- Timely submission of all Production reports such as DPR, WIP etc
- And other periodic data covering different aspects of production and managing manpower ‘s shift schedule for day to day operations
- To participate in evaluation and monitoring of training activities of manpower
- Active production participant during autoclave, tunnel, vial washing machine validation
- Responsible for timely closer of deviation, incident, change control and QMS documentation
- Maintenance of GMP records for production area
- To ensure on - line Completion of BMR/BPR & other document
- Balance calibration
Officer – Production
Mankind Pharma Limited
Paonta Sahib
06.2008 - 10.2010
- Preparation & on line completion of BMR and BPR records
- Batch fabrication and dispensing of primary and secondary packing material
- To coordinate with QA/QC/Stores dep’t regarding day-to-day activity
- To have proper control and proper utilization of work force
- To take part in training programs to follow production as per GMP guidelines
- Maintaining the documentation about Rh, calibration and preventive maintenance of the equipment/machines as per the schedule given by the maintenance department
- Receiving raw material for batch to be manufactured and packing material to be packed and returning MRN, finished goods transfer note for finished product to warehouse
- Responsible for Optical Inspection operation and qualification of Visual Inspector
- To ensure a lean & clean shop floor activity by monitoring daily requests loaded in system for material issuance
Education
Bachelor of Pharmacy -
Skills
- MS - Office automation (Word, Excel, and PowerPoint)
- Well versed with SAP and ERP Module
Training Achievements
- Well conversant with for pharmaceutical drug manufacturing guidelines like WHO guidelines USFDA /MHRA/ Eu.
- Attended training on ‘Quality Management System ISO 9000‘, Production Systems, IPR, EMS.
- Water system, cGMP, HVAC.
- Proactive approach in problem solving and system improvement.
Education Qualification
Bachelor of Pharmacy (1st Division).
Personal Information
- Date of Birth: 03/11/82
- Marital Status: Married
Languages
- English
- Hindi
Audit Purview
- USFDA
- EU-GMP
- WHO-cGMP
- ANVISA
- TFDA
- NAFDAC
Profile Summary - Summary
Dynamic professional with over 9-years’ Experience in Injectable Production (SVP) Liquid, Dry powder and Lyophilization formulation. Functional Expertise in handling the Production Operations with key focus on regulatory requirement and profitability by ensuring optimal utilization of resources. Experience in delegating work schedule, preparing SOP’s, protocols and proficient in implementing audit compliance on shop floor as per cGMP requirement. A result oriented professional and effective leader deft in creating and sustaining dynamic environment that foster the development opportunities and motivate the high performance amongst the team member. A good communicator and ability to work in cross-functional team.
Timeline
Team Leader – Production
DR. Reddy’s Laboratories Ltd.
05.2021 - Current
Senior Executive – Production
Mylan Laboratories Limited
10.2015 - 04.2021
Executive- Production
Nectar Life Science Limited
04.2013 - 09.2015
Executive – Production
Ind Swift Limited
11.2010 - 03.2013
Officer – Production
Mankind Pharma Limited
06.2008 - 10.2010
Bachelor of Pharmacy -
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