Key skills
RStakeholder ManagementCollaboration
About this role
Senior Executive - CQA
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
• 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.
• Imparting training on Corporate Procedures and Policies as per requirement.
Work Experience
9-11 years of Experience in Quality, QMS and Compliance functions. Work experience in Corporate Office would be an added advantage.
Education
Post Graduation in Science
Masters in Pharmacy or Life Science
Competencies
Strategic Agility
Innovation & Creativity
Customer Centricity
Developing Talent
Result Orientation
Process Excellence
Collaboration
Stakeholder Management