About QUICQ GMP CONSULTANCY SERVICES

Smita Patel

Smita Patel by Qualification Bachelor of Pharmacy, leveraging over two decades of experience- spanning the areas of Shop floor Quality functions, Stability Functions, Microbiology, Vendor Management, Audit & Compliance, Quality Management Systems, Training ,Technology Transfer Documentation and RnD Quality functions. Competent in Consulting with Gap Analysis, Training, Auditing and "Implementation" of Learning.

Smita started career in 1995 where she was involved in the shop floor Quality assurance function of various dosage forms like Tablet, Hard capsule, Soft Capsules , Injectables and Transdermals. Handling Document Management system and faced various regulatory Audits.

In 2007 she joined at well known RnD facility. During this tenure Smita lead various roles and projects with respect to RnD Quality functions, GMP, Technology Transfer Documentation, Automation, Lean system. PAT Implementation.

Has played a crucial role in designing and set up of the GMP systems and documentation for new set up of FnD--oncology and Topical department. Holds the core competency of designing and understanding formulation development and Technology Transfer documentation and training on various Quality Systems. Understanding and implementation on Lean documentation system through automation and Paperless system.

During Entire journey Smita has conducted 100 + internal audits of various department both of GMP and Safety as per GMP, GLP, ICH Q7 and ISO-safety guidance’s. Her auditing experience has involved conducting in-depth audit with specific focus on data integrity and GMP point of view in various areas of the shop floor. During her tenure she faced various regulatory inspections like USFDA, EMA, ANVISA, MCC, MHRA, TGA, PMDA and other regulatory agencies.