Shweta Deo
Pune
Summary
- More than 13 years of regulatory experience in the medical device and drug device combination for different regulatory markets.
- Quality Coordinator for product tractability through research and implementation of standards.
- Problem Solving approach with determined and comfortable completing multiple tasks in fast-paced environment to meet quality standards.
- Responsible for coaching and mentoring skills and professionally proactive & ability to learn quickly.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Regulatory & Quality Assurance @
Varian Medical System
Pune
07.2022 - Current
- Working closely with different types of projects/products to monitor and implement quality standards and regulatory requirements.
- Verifying product development and project changes are as per defined internal quality instructions, regulations and quality standards.
- Ensuring seamless transfer of product to production.
- Providing guidance and/or training to project teams on procedures, Design Verification and Validation and Design Controls.
- Reviewing software development lifecycle records for compliance with good documentation practices.
- Preparing Audit planner, audit reports and supporting external audits
- Review Design History Files for conformance to applicable requirements and completeness of project.
- Preparing Quality Review Board and management data to foresee business need and Impact.
- Review and approval of product defects, product feedback and customer complaint.
- Working on Non-conformance and corrective & preventive actions (NC-CAPA).
- A site SME of learning and development.
Associate Scientist
Lupin Limited
Pune
08.2010 - 07.2022
- Document Control/Review for Method Validations, Method Verifications, Drug Product Characterization, Audit Compliance reports, In-vitro Studies & Investigation Reports as per regulatory guidelines. Preparation/Review of Standard Test Procedures, Standard Operation Procedure, Investigation of OOS (Out of Specification Result).
- Implementation of LIMS (Laboratory Inventory Management System) as per CFR 21 Part 11 for electronic data record and document Control/Review of Instruments/Equipment’s software Qualifications/Maintenance through Change Control QAMS.
- Working on human respiratory simulations and automated machines for patient Inuse Study and Drug-Device combination studies.
- Working as team leader/team coordinator for assigned task and delivering timely response.
Education
Master of Science - Biochemistry
Dr. D.Y. Patil University
Navi Mumbai, Maharashtra, India06-2009
Bachelor of Science - Zoology
The Maharaja Sayajirao University (MSU)
Vadodara, Gujarat, India06-2007
Skills
- Proficient user in different Quality Management System tools
- Expertise in compliant quality standards
- Guidelines Handson : ISO 13485:2016, ISO 14971, 21 CFR Part 820 (QSR),EU-MDR
- IEC 62304-2006A1-2015-Medical device software Software Lifecycle processes , IEC 82304
- Medical device single audit program (MDSAP)
- Health Insurance Portability and Accountability Act(HIPAA)
- Protected Health Information (PHI)
- Understanding of 510(k) submission PMA, CE Marking
- Knowledge of software development life cycle (SDLC)
Languages
Marathi
First Language
English
Proficient (C2)
C2
German
Elementary (A2)
A2
HIndi
Proficient (C2)
C2
Gujarati
Proficient (C2)
C2
Affiliations
- Trekking , Hiking, Yoga & Meditation, Music Recreation & Voice Modulation.
Medical Devices
Regulatory Affairs & Quality Assurance (RA / QA)
Certification
- Certified from BSI as CQI and IRCA Medical Devices – Quality Management Systems Auditor/Lead Auditor & Medical Device Single Audit Program (MDSAP) Fundamentals and Readiness Training Course.
NSF (National Sanitation Foundation) certified
- FDA Inspections of Medical Device Manufacturer,
- Medical Device Complaint Handling and Servicing
- ISO 14971:2019 - Application of Risk Management to Medical Device
- FDA Medical Device Reporting Requirements
- Design Controls for Medical Devices and IVDs
- U.S Quality Systems and Combination Products
- FDA Medical Device Inspection
Internally certified Learning & Development site co-ordinator
Accomplishments
- Participated and presented in "Global Design Quality workshop" at Varian Medical System , California USA.
- Awarded with special recognition from cross functional teams for special contribution for project completion.
- Received Stock options of Lupin shares being consistent performer above the plan
- Recognized and awarded for valuable contribution in the Complex Generics for FDA approval of asthma drug.
References
References available upon request.
Timeline
Regulatory & Quality Assurance @
Varian Medical System
07.2022 - Current
Associate Scientist
Lupin Limited
08.2010 - 07.2022
Master of Science - Biochemistry
Dr. D.Y. Patil University
Bachelor of Science - Zoology
The Maharaja Sayajirao University (MSU)
- Certified from BSI as CQI and IRCA Medical Devices – Quality Management Systems Auditor/Lead Auditor & Medical Device Single Audit Program (MDSAP) Fundamentals and Readiness Training Course.
NSF (National Sanitation Foundation) certified
- FDA Inspections of Medical Device Manufacturer,
- Medical Device Complaint Handling and Servicing
- ISO 14971:2019 - Application of Risk Management to Medical Device
- FDA Medical Device Reporting Requirements
- Design Controls for Medical Devices and IVDs
- U.S Quality Systems and Combination Products
- FDA Medical Device Inspection
Internally certified Learning & Development site co-ordinator
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