Smita Georgie

About Smita Georgie

Analytical and achievement driven, Head of Audit & Compliance with over 15 years of…

Experience

1. Head - Audit & Compliance

   Sandoz India

   Feb 2016 — Present · Mumbai, IN

   Head – Audit & Compliance • Tracking and analyzing Key Quality performance Indicators to ensure alignment with regulatory standards.• Implementation of Global Standards: Extensive experience in establishing and integrating global compliance frameworks across multiple sites.• Managing organizational Change Management initiatives to optimize processes and meet evolving regulatory demands.• Designing and executing robust self-inspection processes to identify and mitigate compliance risks.• Developing and implementing compliance training programs for employees, enhancing their understanding of regulations and standards.• Conducting risk assessments and implementing mitigation strategies for Quality Assurance.• Investigating deviations, OOS’, analyzing trends to implement effective corrective and preventive actions.• Inspections faced successfully: USFDA, EU, ANVISA, Russia, Uganda, Belarus, Taiwan, Tunisia and Indonesia.Head – Microbiology • Implementation of current industry best practices for effective and compliant functioning of the Microbiology laboratory.• Lead the Solids Network Forum for optimization with respect to microbial testing and monitoring in non- sterile manufacturing.• Continuous improvement initiatives and effective inventory management of Laboratory consumables.• Analytical Method Transfers, Microbial Method validation activities.

Education

• University of Mumbai

  Master's degree

  1997 — 2002

• Smt. C H M College

  HSC

  1995 — 1997

• P M M Inner Wheel School

  SSC

  1983 — 1995

Skills

• Hplc
• Marketing Strategy
• Regulatory Affairs
• Technology Transfer
• Six Sigma
• Validation
• Pharmaceutical Industry
• Sop
• Fda
• Gmp
• Capa
• Project Management
• Quality Assurance
• Glp
• Quality System
• V&V
• Formulation
• Analytical Chemistry