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Trupti Bhagat

@truptibhagat

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Accomplished QARA professional with 16 years of expertise.

Australia

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What I'm looking for

I seek a role that fosters continuous improvement and values quality assurance.

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.

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Experience

Work history, roles, and key accomplishments

Current

Senior Executive II

Current

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.

ISO 13485 MDSAP Audit Management Quality Management Systems Regulatory Compliance Continuous Improvement Team Leadership Project Management

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.

Regulatory Affairs Product Registrations Compliance Management Project Management

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.

Quality Assurance ISO 9001 ISO 13485 Root Cause Analysis

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.

Product Registrations ISO 13485 Compliance Management Team Leadership

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.

Quality Assurance Documentation Management Training SOP Development

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.

Auditing Good Manufacturing Practices Quality Assurance