Nilofer Shaikh

About Nilofer Shaikh

To be part of a growing & dynamic organization that provides ample opportunity for…

Experience

1. Senior Quality Assurance Manager at Indegene

   Indegene

   Mar 2023 — Present

   Support implementation, execution and performance oversight of the Quality Management System (QMS) for the relevant functional department and ensure readiness for external audit and inspections• Plan and execute QA audits (internal/external audits, activities, critical processes) and generating audit reports that clearly communicate complex observations, as applicable.• Review RCA/CAPA document and effectiveness checks for both internal identified issues and client escalated issues, deviations etc• Support in client audits and regulatory inspections, as required serve as single point of contact before, during and after external audit.• Review and monitor Regulatory guidelines and information sources to keep updated on current regulations, practices, and procedures.• Assist in the preparation of Key Performance Indicators (KPIs) for performance monitoring and management oversight and project specific quality management plan.• Advise stakeholders on GxP best practices.• Develop/update/contribute in development and maintenance of Standard Operating Procedures (SOPs) and training materials.• Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy

Education

• Maharashtra University of Health Sciences

  B.H.M.S; HSC

  2001 — 2004

• Sikkim Manipal University

  Msc, Clinical Research and Regulatory Affairs

• IMAA

  Post Graduate Diploma, Accupuncture

Skills

• Clinical Research
• Pharmacovigilance
• Quality Control
• Sop
• Fda
• Drug Safety
• Healthcare
• Clinical Trials
• CRO
• Gcp
• Teamwork
• Ich-Gcp
• Medical Writing
• Clinical Data Management
• Time Management