Amruta Phansekar
Mumbai
Summary
Assistant Manager-Quality System (GMP/GDP)with over 11 years of experience in GMP and GDP compliance within the pharmaceutical industry. Expertise in managing and implementing robust Quality Management Systems (QMS) to ensure regulatory and business requirements are met. Proven ability to lead quality improvement initiatives, conduct audits, and deliver compliance training across multiple sites. Strong background in maintaining license's and authorizations, performing gap analysis, and driving process improvements. Adhere with a commitment to operational excellence and continuous improvement.
Overview
10
10
years of professional experience
Work History
Assistant Manager-External Supply Quality( GMP/GDP
GlaxoSmithKline Inc.
12.2021 - Current
- Acted as the Training Coordinator, managing organizational, personnel, and training documentation, including records, matrices, and curricula.
- Expert in Customer management and qualification for commercial business.
- Conducted gap analyses for products, ensuring alignment with company and pharmacopeial standards.
- Identified training needs, developed training plans, and conducted induction, ongoing, and refresher training on hygiene, safety, and GxP standards.
- Served as the CAPA champion, reviewing CAPAs for all External Supply functions and escalating exceptions to the Quality Council.
- Led the Risk Management Process, identifying potential risks and managing them through the RMS framework.
- 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
- To ensure all the KPI targets for relevant profiles are achieved and provide the relevant data/updates in this regard to ES Quality council & Regional Quality council and other forums
- 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, Quality team and Quality Bulletins for applicability to ES India.
- Played a pivotal role as the Responsible Person, ensuring strict GDP compliance of wholesale distribution activities within the GSK India Commercial Quality marketplace, resulting in error-free operations in cold chain products and uninterrupted supply chain activities.
- Acted as the primary liaison for GxP quality system audits conducted
by GSK Global Quality Audits (GQA), achieving exemplary audit
outcomes and maintaining a reputation for excellence in quality
management.
Associate Manager - Quality Management System
Johnson & Johnson (Janssen Cilag)
11.2017 - 12.2021
- Managed change management and CAPA in Trackwise for both commercialized products and early development projects.
- Prepared and reviewed specifications, stability statements, and dossier submission justifications.
- Participated in Self-Inspections and USFDA audits, ensuring timely and accurate documentation.
- Conducted training sessions on non-conformances and new electronic Quality Management systems.
Officer - Corporate Quality Assurance
Alkem Laboratories Ltd
08.2014 - 11.2017
- Monitored and managed 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.
- Oversaw CAPAs associated with complaints through site visits and audits.
Education
PGPDSBA (AI & ML) - Data Science
University of Texas (Great Learning)
Online03.2024
Master of Pharmacy-Pharmaceutics - undefined
University of Mumbai
06.2014
Skills
- Leadership
- Strong Communication Skills
- Time Management
- Adaptability
- Problem Solving
- Attention to detail
- Decision making
Languages
English
Hindi
Marathi
Personal Information
Title: Assistant Manager-Quality Management System
Timeline
Assistant Manager-External Supply Quality( GMP/GDP
GlaxoSmithKline Inc.
12.2021 - Current
Associate Manager - Quality Management System
Johnson & Johnson (Janssen Cilag)
11.2017 - 12.2021
Officer - Corporate Quality Assurance
Alkem Laboratories Ltd
08.2014 - 11.2017
PGPDSBA (AI & ML) - Data Science
University of Texas (Great Learning)
Master of Pharmacy-Pharmaceutics - undefined
University of Mumbai
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