KRISHNA SHARMA
Senior executive
Patna,BR
Summary
To associate with leading organisation with innovative ideas and to work in a position where knowledge is utilized in the best possible way, which provides area of an opportunity for growth in professional career and that contribute to the growth of organization.
Result-driven professional offering over 12+ years of experience in productivity and complying the standards and regulatory bodies to ensure quality of product in oral solid dosage formulation pharmaceutical industries. Hands-on experience in facing WHO, MHRA, PDMA and USFDA audits, ensured audit compliance & timely closure of audits observations. Initiation of change controls and providing related documents to close the same. Impressive success in implementing various standards to improve and implement the Product Quality, Deviations, Change Control, CAPA, Investigations. Effective in managing risk analysis and initiating measures to reduce risks in the product quality.
Overview
13
13
years of professional experience
2012
2012
years of post-secondary education
4
4
Languages
Work History
Sr. executive Production
USV Pvt. Ltd.
08.2023 - Current
- Co-ordination with different departments for completion of day-to-day activities.
- Capable of handling the shifts independently with a strength of 50-60 manpower.
- Initiation of change control of different aspects of site and to work for the closure along with providing the suitable evidence.
- SPOC for maintaining the OEE of the department and related data compilation.
- Handling E-BPR and E-log of Pass X application.
- Liaise with managers of different departments to determine training needs and schedule training sessions.
- Analyze training needs and design training programs accordingly to make it more effective as per target audience interest.
- Follow up for timely completion of trainings for closure of CAPA and other QMS tools.
- Handling QMS activities through track wise application and ensure timely closure of the raised events/incidents.
- Conducting FMEA with the help of SME's and preparing the effective protocols accordingly.
Executive Production
Sandoz (A Novartis division)
11.2021 - 07.2023
- Currently working as production executive.
- Handling MES system for day-to-day activities as per regulatory guidelines.
- Co-ordination with different departments for completion of day-to-day activities.
- Initiation of change control of different aspects of site and to work for the closure along with providing the suitable evidence.
- Collaboration with different department and to provide the timely evidence for closure of change controls.
- To focus solely on the cGMP along with customer satisfaction.
- Follow up for timely completion of trainings for closure of CAPA and other QMS tools.
- Handling QMS activities through track wise application and ensure timely closure of the raised events/incidents.
- Conducting FMEA with the help of SME's and preparing the effective protocols accordingly.
Executive Production
Sun Pharma Laboratories Limited
08.2015 - 02.2021
- Handling deviation, change control and market complaints for packing section through Track wise application.
- Conducting Root Cause Analysis & Impact Assessment for closing deviation & investigating issues; proposing various Corrective and Preventive Action Plans (CAPA).
- Observing procedures and assuring adherence to SOPs & practices as defined by organization; scheduling revision through EDMS Application.
- Collaborative review and approval of departmental SOP's through EDMS application.
- Preparing and Reviewing SOPs of various functional sections; participating in internal & external audits.
- Leading training to the members as per calendar schedule for the skill upgradation.
- Execution of daily packing activities as per plan.
- Arrangement of manpower as per their skills and to achieve maximum output with available resources.
- Reviewing BPR (Batch Packing Records); performing in process parameter as per Standard procedure.
- Analysis of rejections generated during machine operation.
- Return of left-over packing material; create work order, BPR issuance request and transfer of packed finished goods through ERP system.
Production Officer
USV private Limited
12.2014 - 07.2015
- To take line clearance on packing lines on daily basis.
- Monitoring of environmental conditions of the area as per frequency.
- Performing in process activities and recording the same in BPR.
- Maintenance of Stereos issuance and destruction record as per procedure.
- Manpower arrangement as per their skills and achieve the given target.
- Return of left-over packing material and transfer the packed goods through FGTN.
Production Officer
Wockhardt Limited
10.2012 - 12.2014
- To take line clearance on packing lines on daily basis.
- Monitoring of environmental conditions of the area as per frequency.
- Performing in process activities and recording the same in BPR.
- Maintenance of Stereos issuance and destruction record as per procedure.
- Manpower arrangement as per their skills and achieve the given target.
- To take line clearance in wet granulation and coating area.
- To perform in process activities of wet granulation and coating and record the same in BMR.
- To perform SFM challenge test as per procedure.
- To perform sieve integrity test and maintain sieve destruction record.
- Process order generation and stage wise entry of product in SAP.
Education
B. Pharm. -
SVCP, PTU
Higher secondary certificate - undefined
Gujarat board
Senior secondary certificate - undefined
Gujarat board
Skills
Production planning
Executive Profile
Result-driven professional offering over 12+ years of experience in productivity and complying with standards and regulatory bodies to ensure quality of product in oral solid dosage formulation pharmaceutical industries., Production planning, Audits & Compliances, Deviation and change control, Market complaint investigation, Manpower management, Developing learning strategies, Skill enhancement, Change management, Data compilation, Involvement in troubleshooting
Interests
Playing cricket
reading books
listening soft music
Equipment Handled
- Blister pack machine: (Hoonga 600 RM, B-Max, BQS, 230 XT, Elmach 300, Rotovac 210 V, TR 100 super, Strip machine etc.)
- Autocartonator machine: (Hi cart plus 6P by ACG, IC 150 C by IMA PG, WKH 100 by Elmach etc.)
- Bottle pack machine: CVC and Countec.
- Track and trace: Optel and Antares.
- Check weigher: (CW 600 and 1200 by Technofour pvt ltd., Anritsu etc.)
- Weighing balance: (SI 810 by Essae and Elderpan 300 etc.)
- Carton sealing machine: (Signoid).
- Inkjet printer (Condot systems pvt ltd, Markem Imaje, Videojet etc.)
- Casepacker machine.
- Vibro sifter: (Gansons).
- Rapid mixer Granulator: (Tapasya).
- Fluid Bed dryer: (Alliance).
- Octagonal Blender: (Shree Bhagwati).
Personal Information
- Father's Name: Mr. Vankteshwar Sharma
- Date of Birth: 11/30/90
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Timeline
Sr. executive Production
USV Pvt. Ltd.
08.2023 - Current
Executive Production
Sandoz (A Novartis division)
11.2021 - 07.2023
Executive Production
Sun Pharma Laboratories Limited
08.2015 - 02.2021
Production Officer
USV private Limited
12.2014 - 07.2015
Production Officer
Wockhardt Limited
10.2012 - 12.2014
Higher secondary certificate - undefined
Gujarat board
Senior secondary certificate - undefined
Gujarat board
B. Pharm. -
SVCP, PTU
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