Trupti Bhagat
@truptibhagat
Accomplished QARA professional with 16 years of expertise.
What I'm looking for
I am an accomplished QARA professional with over 16 years of experience in developing and implementing robust quality assurance systems across the Medical Devices, Pharmaceuticals, and CRO sectors. My expertise lies in conducting rigorous audits and spearheading continuous improvement initiatives, while effectively leading and mentoring high-performing teams. I possess comprehensive knowledge of regulatory requirements and industry standards, having successfully undertaken various roles in quality management, regulatory affairs, and manufacturing.
Throughout my career, I have achieved significant milestones, such as developing regulatory strategies for site expansion projects and obtaining timely approvals from notified bodies for product releases. My experience includes managing compliance to ISO standards, leading quality teams, and driving continuous improvement initiatives. I am passionate about ensuring quality and compliance in all aspects of my work, and I thrive in environments that challenge me to grow and innovate.
Experience
Work history, roles, and key accomplishments
Senior Executive II
Alcon Manufacturing & Logistic
Nov 2019 - Oct 2023 (3 years 11 months)
Managed compliance with ISO 13485 and MDSAP standards, coordinated audits, and led continuous improvement initiatives. Oversaw GXP training and site quality metrics reporting, while supporting regulatory change assessments and site transitions.
Regulatory Manager
Clear lab Pte Ltd
Jul 2019 - Oct 2019 (3 months)
Managed product registration and renewal processes, ensuring compliance with regulatory requirements. Provided strategic regulatory advice and guided the regulatory team in submissions and updates.
Product Quality Lead
Perkin Elmer Pte Ltd
Jul 2018 - Jul 2019 (1 year)
Led investigations of customer complaints and collaborated with cross-functional teams to implement corrective actions. Monitored quality indicators and ensured compliance with ISO standards.
Senior Engineer Quality and Regulatory
Oculus Private Limited
Apr 2015 - Jun 2018 (3 years 2 months)
Led the QARA team in product registration and regulatory inspections across multiple countries. Ensured compliance with ISO standards and managed communication with regulatory bodies.
QA Engineer
GE Healthcare
Jul 2013 - Jan 2015 (1 year 6 months)
Supported quality investigations and documentation updates for new product development. Conducted training and assisted with complaint investigations and non-conformance controls.
Executive to Assistant Manager Quality Assurance
Reliance Clinical Research Services
Aug 2007 - Jul 2013 (5 years 11 months)
Conducted compliance audits for clinical research studies and managed production planning. Ensured adherence to Good Manufacturing Practices and prepared SOPs and batch records.
Education
Degrees, certifications, and relevant coursework
Bangalore University
Master of Science, Biotechnology
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
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