Swapnil Agawane
Senior Expert QA at OmniActive Health Technologies- Claim this Profile
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English Full professional proficiency
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Marathi Native or bilingual proficiency
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Hindi Professional working proficiency
Topline Score
Bio
Ashish kumar Rout
Swapnil is quality oriented, always stick to the basics. His command over shopfloor activities is adorable. Quality driven person at every aspects of QA functions . I wish him success in his all future endeavour.
Ashish kumar Rout
Swapnil is quality oriented, always stick to the basics. His command over shopfloor activities is adorable. Quality driven person at every aspects of QA functions . I wish him success in his all future endeavour.
Ashish kumar Rout
Swapnil is quality oriented, always stick to the basics. His command over shopfloor activities is adorable. Quality driven person at every aspects of QA functions . I wish him success in his all future endeavour.
Ashish kumar Rout
Swapnil is quality oriented, always stick to the basics. His command over shopfloor activities is adorable. Quality driven person at every aspects of QA functions . I wish him success in his all future endeavour.
Credentials
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FSPCA preventive controls for Human Food
SGSOct, 2020- Nov, 2024 -
Certified Lean Six Sigma Green Belt
Exemplar Global, Inc.Sep, 2017- Nov, 2024
Experience
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OmniActive Health Technologies
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United States
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Wellness and Fitness Services
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300 - 400 Employee
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Senior Expert QA
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Mar 2020 - Present
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Assistant Manager QA
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May 2019 - Mar 2020
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Flamingo Pharmaceuticals Ltd
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India
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Pharmaceutical Manufacturing
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400 - 500 Employee
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Assistant Manager Corporate QA
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Jul 2017 - May 2019
Implement and monitor the QMS systems across all FPL sites. Support manufacturing sites for audit preparedness during regulatory authority/ customer audits. Planning and perform internal audits as per schedule. Handling of market complaints of all FPL sites. Review of Artworks and manage change controls related to artwork. Perform review of Elemental impurity risk assessment for Drug products as per ICH Q3D Implement and monitor the QMS systems across all FPL sites. Support manufacturing sites for audit preparedness during regulatory authority/ customer audits. Planning and perform internal audits as per schedule. Handling of market complaints of all FPL sites. Review of Artworks and manage change controls related to artwork. Perform review of Elemental impurity risk assessment for Drug products as per ICH Q3D
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Sandoz India Pvt Ltd
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India
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Executive Quality Assurance
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Jun 2016 - Jul 2017
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Assurace Executive
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May 2013 - Jun 2016
Change control, Deviation, CAPA and Root cause analysis, Periodic/Annual product review, Audit management and Inspection readiness, Batch release, Document Review (draft MFR, SOPs, BMR/BPRs), Line Clearance, In process checks and Risk assessment
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Quality Associate
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May 2012 - Apr 2013
Implementation and adherence of Quality management systems standards at shop floor, management of change controls, deviations, root cause analysis, CAPA, Preparation of Annual product review, batch release, risk assessment, line clearance verification and risk assessment
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Project Intern
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Aug 2010 - May 2011
Preparation of annual product reviews of tablets, liquid orals, creams and ointment dosage forms. Development of analytical method ad its validation. Preparation of annual product reviews of tablets, liquid orals, creams and ointment dosage forms. Development of analytical method ad its validation.
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Education
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2009 - 2011
Sinhgad College of Pharmacy
M. Pharmacy, Quality Assurance Techniques -
2005 - 2009
Sinhgad Institute of Pharmaceuticals, Lonavala
B Pharmacy, Pharmacy -
2002 - 2004
T. C. College, Baramati
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1995 - 2002
M. E. S. Highschool, Baramati
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