Riddhi Thakkar

About Riddhi Thakkar

I have thorough knowledge of Good Manufacturing Practices, Good Documentation Practices and 21 CFR Part 210 & 211.I am a self motivated individual and a quick learner.

Experience

1. Senior Validation Engineer

   Cmic Cmo Usa

   Apr 2022 — Present · NJ, US

   Author and execute validation protocols, such as Installation, Operational, and Performance Qualifications (IOPQs), and Utilities Qualification in compliance with applicable cGMP, FDA, and all other regulatory agencies standards Coordinate Validation Program activities in compliance with CMIC policy and department, local procedures and regulatory expectationsResponsible to plan, manage, and execute the start-up, commissioning, and validation of new or modified equipmentCoordinate with Production, Quality, Maintenance, and other personnel as needed to manage projects, capacity increases, and process improvementsDevelop qualification protocols and retirement documentationConduct field execution of validation deliverables, resolve any deviations, and prepare reportsAssist in managing validation process improvement projects Author, review and update Standard Operating Procedures for manufacturing and packaging equipmentFollow Pharmaceutical industry standards in generating and updating supporting documentation such as P & IDs, material and equipment specifications, and requirement specificationsWork within cross-functional teams; communicates progress effectively to other team members and validation managementMaintain safe working environmentSupport 3rd party validation activities, where applicableComplete assigned validation projects in timely mannerMaintain and improve job knowledge and skills by remaining current in industry trends, by attending educational seminars, reading professional publications, and participating in professional organizations. Perform other special projects and duties as assigned by department management

Education

• Sigma Institute of Pharmacy

  Bachelor's Degree, Pharmacy

  2008 — 2012

• Rowan University

  Master’s Degree, Pharmaceutical Sciences

  2014 — 2016