Amruta Phansekar
Assistant Manager-External Supply Quality
Mumbai
Summary
Experienced Operations Strategy and Quality Assurance professional with over 11 years of expertise in transforming complex processes into strategic advantages. Adept at implementing innovative solutions, driving operational excellence, and ensuring compliance across GMP, GDP, and regulatory landscapes. Proven ability to lead cross-functional teams, manage large-scale projects, and align operations with business objectives.
Overview
10
10
years of professional experience
3
3
Languages
Work History
Assistant Manager-External Supply Quality
GlaxoSmithKline Inc.
12.2021 - Current
- Spearheaded a critical product recall, ensuring regulatory compliance and reducing customer impact within 2 weeks.
- Improved supplier audit outcomes by 30% through risk-based planning and process improvements.
- Led QMS compliance for external manufacturing sites and distribution centers.
- Conducted management review meetings to analyze metrics and implement corrective actions.
- Manage organizational, personnel, and training documentation as a Training Coordinator, overseeing training records, matrices, and curricula
- Escalate any exceptions in CAPA Management in Quality Council or ES Governance forums.Carry out an annual review of the process to identify improvement
- To review the effectiveness of global CAPA implementation
- Drive Risk Management Process to build Risk Assessment/ Management culture in ES Quality i.e identification of potential risk while performing day to day activities and management of identified risk through RMS
- Review all Quality Alerts and Quality Bulletins for applicability to ES India Rx
- To prepare monthly metrics report to track closures and overdue critical quality events
Associate Manager - Quality Management System
Johnson & Johnson (Payroll Labcorp Inc)
11.2017 - 12.2021
- Managed market complaints, self-inspections, and regulatory compliance for US FDA and global standards.
- Designed and executed training programs to foster a compliance-oriented culture.
- Utilized digital tools like Veeva QMS, TruVault, and SAP for process tracking and efficiency.
- Managed change management system and CAPA in Trackwise for commercialized products and early development projects
- Participated in Self-Inspections and USFDA audits, ensuring timely provision of documents
- Conducted trainings for non-conformances and new electronic Quality Management systems
Officer - Corporate Quality Assurance
Alkem Laboratories Ltd
08.2014 - 11.2017
- Handled and monitored QMS activities, including market complaints, change controls, and self-inspections of manufacturing facilities
- Ensured compliance with regulatory requirements such as ICH, US FDA, and Schedule M
- Monitored CAPAs associated with complaints through site visits
- Monitored CAPA associated with market complaints and conducted internal audits.
- Ensured adherence to ICH, US FDA, and Schedule M requirements.
- Established effective relationships with key stakeholders both internally and externally for increased collaboration opportunities.
Education
Masters of Pharmacy - Pharmaceutical Sciences
University of Mumbai
Mumbai 04.2001 -
PGPDSBA - Data Science
University of Texas
Great Learning 04.2001 -
Skills
- Strategy Development & Execution
- Regulatory Compliance & Risk Management
- Process Optimization & Digital Transformation
- Cross-Functional Collaboration & Client Engagement
- Data Analysis & Insight-Driven Decision Making
- Quality Management Systems (QMS)
- Product Recall & Field Action Management
- Supplier & Distributor Audit Management
- CAPA & Non-Conformance Management
Accomplishments
- Led a project to redesign operational workflows, reducing process time by 40% and enhancing efficiency across departments
- Ensured 100% compliance with global regulatory standards during US FDA inspections, with no observation
Timeline
Assistant Manager-External Supply Quality
GlaxoSmithKline Inc.
12.2021 - Current
Associate Manager - Quality Management System
Johnson & Johnson (Payroll Labcorp Inc)
11.2017 - 12.2021
Officer - Corporate Quality Assurance
Alkem Laboratories Ltd
08.2014 - 11.2017
Masters of Pharmacy - Pharmaceutical Sciences
University of Mumbai
04.2001 -
PGPDSBA - Data Science
University of Texas
04.2001 -
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