Chromeleon 7210 , Chromeleon 68, Empower 3, Lab Solution and Labx
Ashwani Sharma
Manager Quality Control
Indore
Summary
Diligent Quality Manager with 14+ years of experience in pharmaceuticals industries,Skilled in Team management ,Project management and statistical analysis, excellent analytical skills and having Problem solving approach. Lean Six Sigma Black Belt Trained from BMGI. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
14
14
years of professional experience
9
9
years of post-secondary education
Work History
Quality Control Manager
Macleods Pharmaceuticals Limited
Pithampur, Madhya Pradesh
03.2023 - Current
- Planning and execution of analytical method transfer, method verification and method validation activities as per regulatory requirements.
- Preparation and review of analytical protocols and reports (Analytical method validation/verification/transfer, method equivalency etc.).
- Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork.
- Saved company cost by implementing cost-saving initiatives that addressed long-standing problems.
- Developed and implemented performance improvement strategies and plans to promote continuous improvement.
- Handling and Monitoring of LCMS Analysis like Nitrosamine Impurities.
- Increased productivity and compliance by 50 % through implementing preprinted test data sheet of individual project.
Senior Manager Quality Control
Cadila Pharmaceuticals Limited
Dholka Ahmadabad
10.2022 - 03.2023
- Monitoring of overall QC activities of Penicillin and Cephalosporin Block .
- Handling 10 members team. Heading analytical method transfer/validation/verification/process validation and Life Cycle Management .
- Planning and execution of analytical method transfer, method verification and method validation activities as per regulatory requirements.
- Preparation and review of analytical protocols and reports (Analytical method validation/verification/transfer, method equivalency etc.).
- Planning of daily IP/FP/Stability/RM/AMT sample analysis as per priorities Responsible for investigation of laboratory incidents, Out-Of-Specification (OOS) results, deviations and CAPA implementation.
- Used coordination and planning skills to achieve desired results.
- Developed team communications and information for meetings. Resolved conflicts between Quality team members.
- Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork.
- Saved company cost by implementing cost-saving initiatives that addressed long-standing problems.
- Developed and implemented performance improvement strategies and plans to promote continuous improvement.
- Participated in team-building activities to enhance working relationships and environment. Received and processed stock into inventory management system.
- Identified issues, analyses information and provided solutions to problems.
- Calibration lead time decreased by 25 % than earlier. Involve in Qualification of contact laboratory.
Manager Quality Control
Lupin Limited
Nagpur
12.2018 - 10.2022
- Stability Management- Planning and Monitoring of stability analysis of commercial and exhibits samples , Monitoring of stability chambers activities. Involve and timely response of regulatory queries and Regulatory filing Activities.
- Finished Product Management- Daily Planning and Execution of Finish Product , In-Process, Hold Time Cleaning and Validation samples.
- Planning of daily IP/FP/Stability/RM/AMT sample analysis as per priorities.
- Actively Involved in AMT/AMV/Analytical method verification/ pharmacopoeia update and LCM Activities.
- QAMS Management- Review, implementation and closure of Change Control and CAPA.
- Investigations of Laboratory Incidents, OOS, OOT and Deviation.
- Involve in Regulatory audits and its Compliance.
- Technical Training and Emphasize on Competency Assessment and on-job training.
- Sample Managements of Finished Products, In-Process, Hold time, Stability and Validation samples.
- World class laboratories implementation - 5S Restoration of Basic Conditions Implementation and involves in various initiative for reduction of invalid OOS/OOT and Laboratory Incidents.
- Cost Saving actively involve in various cost saving initiatives in quality control Laboratory.
- Problem Solving - Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork.
- Reduction of laboratory incidents by 40 % than earlier. Established timeline for QAMS activities.
Quality Control Manager
Piramal Enterprises Limited
Pithampur, Madhya Pradesh
02.2018 - 11.2018
- GLP activities- Analytical instruments calibrations, working standard qualification, column management, software qualifications.
- Involve in Regulatory audits and its Compliance. Involve in various Laboratory Improvements Projects.
- Setup of QC laboratory- Installation and Qualification of instruments Qualification of standalone and server based software.
- Involve in IT Compliance of QC instruments and software's as per 21 CFR.
- Reduction in laboratory incidents by 35 % than earlier. Implemented online calculation sheet in empower software which increased productivity and compliance level.
Sr. Executive & Section in Charge Quality Control
Lupin Limited
Pithampur, Madhya Pradesh
08.2011 - 01.2018
- GLP Activities- Analytical Instrument calibrations, Standard Management , Column Management through SAP, Software Qualifications, Quality Management system and Technical Training in USFDA and MHRA Approved Plant.
- Planning of daily IP/FP/AMT/ WS sample analysis as per priorities. Actively Involved in AMT/AMV Activities.
- Involve in Regulatory audits and its Compliance. Involve in Laboratory Improvements projects.
- Setup of QC laboratory- Installation and Qualification of instruments Qualification of standalone and server based software.
- Involve in IT Compliance of QC instruments and software's as per 21 CFR. Successfully installed & Qualified Lab-X software with Mettler Instrument.
- Calibration time of instrument reduced by approx.50 % from earlier by improvement. Established time required for HPLC calibration i.e. from 5 days to 3 days per HPLC system.
Quality Control Officer
Intas Pharmaceuticals Limited
Mazitar, Sikkim
08.2010 - 08.2011
- GLP Activities- Instruments Calibration and working standard qualification.
- Performed Finished Product Analysis Performed Raw Material Analysis.
- Implemented Validated calculation sheet for results calculation of Finished product as well as Raw material which increased productivity and compliance level.
- Approx. 50 % efficiency increased by implementation of validated calculation sheet. Basic Idea of IPQA like Line Clearance in Different Mfg. Area, in process check etc.
Trainee Officer
Alkem Laboratories Limited
Kumerek, Sikkim
08.2009 - 07.2010
- Performed Raw material and Finished Product Analysis.
- Documentation Activities like preparation and review of Standard Test Procedure, Standard Operating Procedure Preparation.
- Sampling of Raw materials.
- Analysis of Raw Material increased by 50 % than earlier.
Education
Master of Science - Chemistry
VBS Purvanchal University - SBPG Collage
Varanasi 07.2007 - 06.2009
Diploma in Computer Application - Computer Science
Institute For The Professional Development
Varanasi 03.2006 - 09.2006
Bachelor of Science - Chemistry
VBS Purvanchal University-UP Collage
Varanasi 08.2003 - 07.2006
Higher Secondary - Science
SBI Collage
Varanasi 07.2001 - 08.2003
Senior Secondary - Science
HBI Collage
Varanasi 08.1999 - 07.2001
Skills
Technical Training & Demonstration of Quality procedure
Accomplishments
- Successfully faced audit by USFDA ,MHRA UK, QP, ANVISA BRAZIL, HEALTH CANADA , WHO.
- Certification by Lupin for driving quality culture training programs.
- Certificates by waters corporation for training of online calculation through custom field in Empower software.
- Implementation of online printing mechanism of Dissolution Apparatus.
- Implementation for management of standards and column through SAP.
- Successfully completion of Installation and qualification of Labx Sever Based Software.
- Approved Competent Technical Analyst in Chemical and instrumentation.
- QC team handling more than 45+ persons.
Software
Microsoft Office, Minitab , SABA,QAMS and TrackWise QMS
Interests
Lean Six Sigma, 5S
Computer System Validation
RDF, Excel sheet validation & templates Preparation
Auditing different laboratory to ensure regulatory compliance
Timeline
Quality Control Manager
Macleods Pharmaceuticals Limited
03.2023 - Current
Senior Manager Quality Control
Cadila Pharmaceuticals Limited
10.2022 - 03.2023
Manager Quality Control
Lupin Limited
12.2018 - 10.2022
Quality Control Manager
Piramal Enterprises Limited
02.2018 - 11.2018
Sr. Executive & Section in Charge Quality Control
Lupin Limited
08.2011 - 01.2018
Quality Control Officer
Intas Pharmaceuticals Limited
08.2010 - 08.2011
Trainee Officer
Alkem Laboratories Limited
08.2009 - 07.2010
Master of Science - Chemistry
VBS Purvanchal University - SBPG Collage
07.2007 - 06.2009
Diploma in Computer Application - Computer Science
Institute For The Professional Development
03.2006 - 09.2006
Bachelor of Science - Chemistry
VBS Purvanchal University-UP Collage
08.2003 - 07.2006
Higher Secondary - Science
SBI Collage
07.2001 - 08.2003
Senior Secondary - Science
HBI Collage
08.1999 - 07.2001
Similar Profiles
SUNIL JADHAVSUNIL JADHAV
Senior Executive-QC at Macleods Pharmaceuticals LimitedSenior Executive-QC at Macleods Pharmaceuticals Limited
Nikita GhatageNikita Ghatage
Jr. Officer - Regulatory Affairs at Macleods Pharmaceuticals LimitedJr. Officer - Regulatory Affairs at Macleods Pharmaceuticals Limited
Ashwani SharmaAshwani Sharma
Quality Control Manager at Macleods Pharmaceuticals LimitedQuality Control Manager at Macleods Pharmaceuticals Limited