Vijay Kumar Vashishtha
House No-38,Vill-Ghaghpura,Fathehabad,Agra,UP
Summary
Quality professional proposing an illustrated experience of nearly 20 years in the pharmaceutical quality domain. A result-oriented, versatile, and achievement-driven professional with experience meeting business needs in a fast-paced, expanding environment.
Front led a major role in the review and approval of QMS documents, such as Change Control, Deviations, and Corrective and Preventive Action (CAPA).
Led the quality functions: method introduction and setup, calibrations, and routine PM of lab equipment, with regular audits (internal and external).
Analyzed and interpreted unique problems, with a combination of training experience and logical thinking; applied quality tools and identified process bottlenecks and product deficiencies.
Established and reviewed KPIs and Quality Metrics Scoreboard across sites to provide insight to senior management on the current compliance level of the organization.
Overview
20
20
years of professional experience
Work History
Group Leader (NPQC Manager)
SunPharma Limited
Paonta Sahib
04.2023 - Current
- To provide leadership and direction to the group involved in the analysis of process validation, in-process, finished products, and stability samples of exhibit batches.
- Ensure timely testing and approval of all test samples as per approved specifications, STP, and customer requirements. Coordinate and prioritize sample testing with the PDL and Production department, and schedule.
- EB, RM, PM, AMT, CMV, and PV coverage as necessary to support them while minimizing delays.
- Manage budget and resource planning, monitoring, and control of manpower, equipment usage, instruments, facilities, spares, and maintenance of instruments and equipment in the lab to accomplish workload requirements.
- Ensure conformance to internal Quality Systems requirements and relevant markets' regulatory guidelines on CGMP, with respect to testing requirements.
- Responsible for laboratory compliance.
- Review and approval of test reports, data summary reports, certificates of analysis, and method validation/verification transfer protocols and reports for accuracy and completeness.
- Conduct a lab investigation of OOS, OOT observations, market complaints, laboratory incidents, and deviations.
- Responsible for all QMS activities.
- Provide troubleshooting support to analysts in the lab.
- Ensure the qualification of new equipment and calibration as per schedule.
- Provide training on revised SOPs to analysts in the lab.
- Continuous investment (in terms of time and knowledge sharing) in people for their overall development, and to have a successor ready for each role.
Group Leader
Lupin Pharmaceuticals
Jammu
04.2010 - 07.2022
- Responsible for QMS compliance in the QC lab (including laboratory incidents, change controls, deviations, handling of out-of-specification results, and out-of-trend results).
- Specializing in implementing an electronic log system (e-LOG) in a paper-free laboratory.
- Expert in the management of analytical method verification, method validation, technology transfers, analytical method transfers, and method equivalency, including planning, protocol, and report preparation.
- Responsible for maintaining pharmacopeias compliance for the QC lab.
- Review of IP, SFG, FG, RM, and PM Specifications, STPs, and Log Books.
- Ensuring Timely IP, SFG, FG, RM, and PM Analysis of Inhaler and OSD Pharmaceutical Dosage Formulations.
- Responsible for the planning of analysis, review, and UD of raw materials and packing materials in QC.
- Expertise in handling ERP, SAP, Omni-docs, and Electronic Data Management (E-DMS) software.
- Team building and reducing the organization's attrition rate by developing the talent of analysts and improving their analytical and interpersonal skills.
- QC budget and manpower management, including the implementation of cost-cutting measures in the laboratory, if needed.
QC Officer
Ranbaxy Pharmaceuticals Limited
Paonta Sahib
01.2008 - 03.2010
QC Analyst
Rhydburg Pharmaceuticals Limited
Kundli,Haryana
10.2005 - 12.2007
Education
Master of Science - Inorganic Chemistry
Dr. BR Ambedkar University
Agra, India01-2005
Skills
- Selection, supervision, and evaluation of staff
- Excellent problem-solving skills
- Optimistic and hardworking
- Team Management
- Situational Leadership
- Productivity optimization
- Strong communication skills
- Self-confident
- Effective resource utilization
- Quality control
- Data analysis
- Team building
- Conflict resolution
- Risk assessment
- Performance metrics
- Time management
- Critical thinking
- Process improvement
- Regulatory compliance
Affiliations
- A multi-faceted and accomplished professional accustomed to proven skills, targeting challenging and rewarding opportunities in Quality Control/Quality Assurance with an organization of high repute in the pharmaceutical industry
- Total of 19+ years of experience in the field
Accomplishments
- 10+ years award by Lupin
Languages
Hindi
First Language
English
Upper Intermediate (B2)
B2
Timeline
Group Leader (NPQC Manager)
SunPharma Limited
04.2023 - Current
Group Leader
Lupin Pharmaceuticals
04.2010 - 07.2022
QC Officer
Ranbaxy Pharmaceuticals Limited
01.2008 - 03.2010
QC Analyst
Rhydburg Pharmaceuticals Limited
10.2005 - 12.2007
Master of Science - Inorganic Chemistry
Dr. BR Ambedkar University
Personal Details
- Born on January 1, 1983
- Marital Status - Married
- Age - 42 years
- Born in - Agra, Uttar Pradesh
Regulatory Audit Exposure
- Faced with the US FDA, WHO Geneva, the Pharmacy and Poisons Board of Kenya, the Botswana Medicines Regulatory Authority, the Ethiopia Drug Regulatory Authority, Ukraine, Russia, and P2P audits representing the QC Department
Interests and Hobbies
- Reading books
- Cooking food
- Gardening
References
Available upon request
Declaration
- I hereby declare that all the above statements are true and correct to the best of my knowledge and belief
- Date: 03/31/2025
- Place: Paonta Sahib
Soft Skills
- Planner
- Analytical
- Innovator
- Collaborator
- Communicator
IT Skills
- Microsoft Office:
Word, Excel, PowerPoint, SAP
Core Competencies
- Quality Functions
- Process Improvements
- Cost Optimization
- Audits
- Quality Procedures
- Resource Management
- Project Management
- Risk Assessment & Analysis
Personal Details
- Born on January 1, 1983
- Marital Status - Married
- Age - 42 years
- Born in - Agra, Uttar Pradesh
Regulatory Audit Exposure
- Faced with the US FDA, WHO Geneva, the Pharmacy and Poisons Board of Kenya, the Botswana Medicines Regulatory Authority, the Ethiopia Drug Regulatory Authority, Ukraine, Russia, and P2P audits representing the QC Department
Interests and Hobbies
- Reading books
- Cooking food
- Gardening
Personal Details
- Born on January 1, 1983
- Marital Status - Married
- Age - 42 years
- Born in - Agra, Uttar Pradesh
Interests and Hobbies
- Reading books
- Cooking food
- Gardening
Projects
- Successful implementation of stability management through SAP
- Uploading SOPs in EDMS.
- Successful implementation of column management through SA
IT Skills
- Microsoft Office:
Word, Excel, PowerPoint, SAP
Soft Skills
- Planner
- Analytical
- Innovator
- Collaborator
- Communicator
Core Competencies
- Quality Functions
- Process Improvements
- Cost Optimization
- Audits
- Quality Procedures
- Resource Management
- Project Management
- Risk Assessment & Analysis
Regulatory Audit Exposure (Lupin)
- Faced with the US FDA, WHO Geneva, the Pharmacy and Poisons Board of Kenya, the Botswana Medicines Regulatory Authority, the Ethiopia Drug Regulatory Authority, Ukraine, Russia, and P2P audits representing the QC Department
Regulatory Audit Exposure (SunPharma)
- 19/02/2025 - 21/02/2025 SFDA [Saudi Food and Drug Authority], Saudi Arabia
- 18/12/2024 - 20/12/2024 EAFU [Eurasian Economic Union], Russia
- 01/12/2024 - 03/12/2024 CDSCO (Central Drugs Standard Control Organisation), India
- 26/02/2024 - 02/03/2024 Health - Canada, Canada
- 05/02/2024 - 09/02/2024 SMDC [State Service Of Ukraine On Medicines And Drugs Control], Ukraine
- 31/10/2023 - 03/11/2023 IGZ [Health And Youth Care Inspectorate], The Netherlands
- 19/04/2023 - 21/04/2023 WHO - Geneva [World Health Organization], WHO - Geneva
References
Available upon request
Declaration
- I hereby declare that all the above statements are true and correct to the best of my knowledge and belief
- Date: 03/31/2025
- Place: Paonta Sahib
-
Personal Details
- Born on January 1, 1983
- Marital Status - Married
- Age - 42 years
- Born in - Agra, Uttar Pradesh
Regulatory Audit Exposure (SunPharma)
- 19/02/2025 - 21/02/2025 SFDA [Saudi Food and Drug Authority], Saudi Arabia
- 18/12/2024 - 20/12/2024 EAFU [Eurasian Economic Union], Russia
- 01/12/2024 - 03/12/2024 CDSCO (Central Drugs Standard Control Organisation), India
- 26/02/2024 - 02/03/2024 Health - Canada, Canada
- 05/02/2024 - 09/02/2024 SMDC [State Service Of Ukraine On Medicines And Drugs Control], Ukraine
Interests and Hobbies
- Reading books
- Cooking food
- Gardening
Regulatory Audit Exposure (Prior To SunPharma)
- Faced with the US FDA, WHO Geneva, the Pharmacy and Poisons Board of Kenya, the Botswana Medicines Regulatory Authority, the Ethiopia Drug Regulatory Authority, Ukraine, Russia, and P2P audits representing the QC Department
References
Available upon request
Declaration
- I hereby declare that all the above statements are true and correct to the best of my knowledge and belief
- Date: 03/31/2025
- Place: Paonta Sahib
-
Projects
- Successful implementation of stability management through SAP
- Uploading SOPs in EDMS.
- Successful implementation of column management through SA
IT Skills
- Microsoft Office:
Word, Excel, PowerPoint, SAP
Soft Skills
- Planner
- Analytical
- Innovator
- Collaborator
- Communicator
Core Competencies
- Quality Functions
- Process Improvements
- Cost Optimization
- Audits
- Quality Procedures
- Resource Management
- Project Management
- Risk Assessment & Analysis
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