Rutuja Kale
Mississauga,ON
Summary
Highly motivated and results-oriented Quality Assurance professional with a Master of Science in Drugs, Biologic's, and Medical Device Regulatory Affairs. Proven ability to leverage extensive regulatory knowledge and quality management expertise to ensure GMP compliance and optimize processes within the pharmaceutical industry. Possesses a passion for innovation and effective communication to drive cross-functional collaboration and achieve quality excellence.
Overview
1
1
year of professional experience
1
1
Certification
Work History
Technical Trainee
Zenvision Pharma LLP
Navi Mumbai, Maharashtra, India
06.2020 - 06.2021
- Collaborated with cross-functional teams to develop solutions for identified issues related to product or service quality.
- Analyzed production accuracy to formulate corrective action plans.
- Applied advanced ICH Q11 principles and maintained adherence to Good Laboratory Practices (GLP), contributing to a remarkable 20% increase in customer satisfaction scores by implementing enhanced formulation methods.
Education
Master of Science - Regulatory Affairs And Quality Assurance
Northeastern University
Toronto, ON12-2023
Bachelor of Science - Pharmacy
Savitribai Phule Pune University
Pune, India06-2020
Skills
- Project Management
- Regulatory landscape navigation
- Data Analysis& Inspection
- Cross-functional collaboration
- GMP compliance
- Health Canda
- EU MDR Regulatory standards
- ISO 13485 standards
- FDA regulations
- Product Development
- ICH Q guidelines
Languages
English
Professional
Hindi
Professional
Certification
· Internal Auditing for QMS for Medical Devices based on ISO 13485:2016 - TUV SUD South Asia.
· Medical Device Establishment Licensing and Post-market Regulation - Health Canada
Organization
- Member of American Society of Quality (ASQ)
Timeline
Technical Trainee
Zenvision Pharma LLP
06.2020 - 06.2021
Master of Science - Regulatory Affairs And Quality Assurance
Northeastern University
Bachelor of Science - Pharmacy
Savitribai Phule Pune University
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