This position is responsible for the Corporate Quality Function at Lupin, covering the governance of Corporate Quality procedures and governance documents, Regulatory guideline gap assessments, Handling of QMS activities, Conducting CTL Audits, Handling of Quality Technical Agreements and Quality projects.
• This position works closely with other Organizational functions like R&D, Site Manufacturing and Quality Departments, Corporate IT.
• Preparation and review of Corporate procedures and governance documents and keeping them updated with the cGMP requirements.
• Ensuring CQA SOPs are prepared and revised on due date as per SOP on SOP through Veeva DMS. Tracking timely implementation of CQA SOPs at Lupin sites.
• Maintaining 100% compliance with SOP curricula, GMP training and Functional Training.
• Review of new SOPs from sites related to operations and quality system.
• Support the Veeva QMS, DMS enhancements, Quality projects and other improvement initiatives.
• Regulatory Gap Assessment and Compliance monitoring for implementation of regulatory guidelines.
• Handling of QMS activities /support for QAMS in routine activities. Tracking and execution of the QMS records (change controls, deviations, CAPA, effectiveness checks, risk assessments) in the system for their on-time closure and monitoring in close coordination with Lupin Sites/Corporate teams.
• Handling of Documentation activities related to the QMS function.
• Review and coordination with Lupin sites, supply chain, legal, regulatory affairs and customers for finalization of API and finished product Quality technical agreement of all manufacturing sites of Lupin
• Conducting Audits of Contract Testing Laboratories.
• Identifying improvement areas and planning and supporting new initiatives in cGMP and regulatory compliance and Quality standards and support to Lupin sites during audits and inspections.
• Imparting training on Corporate Procedures and Policies as per requirement.
8-10 years of Experience in Quality, QMS and Compliance functions. Work experience in Corporate Office would be an added advantage.
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
