Vaishali Sharma

Quality Assurance Engineer with 7+ Years of experience in Design, Commissioning and Qualification of Bio-pharmaceutical Equipment.

-Involved in preparing validation master plans, overseeing the validation lifecycle (URS,FRS,DQ,FAT,SAT,IQ,OQ) of Upstream and Downstream Equipment along with associated Clean and Black utilities.

-Involved in developing Qualification protocols for moderate to complex C&Q Projects using risk based approach that meets regulatory requirements and industrial practices.

-Reduced efforts in terms of timelines and qualification resources using concept of integrated C&Q and leveraging.

Key activities and responsibilities:

1. Review of concept design for greenfield/brownfield projects along with GMP review of Layouts for man-material flow.

2. Preparation and review of VMPs,Risk reviews and Impact Assessments for manufacturing equipment.

3. Involved in reviews of User requirements and enhanced design reviews ensuring traceability is achieved and design meets the industrial standards.

4. Development of C&Q protocols focusing on testing of critical aspects, eliminating redundant testing using leveraging approach and establishing traceability to the user specific requirements.

5. Involved in discrepancy assessments and change managements applicable in C&Q lifecycles and preparing summary and handover reports.

6. Overall responsible for tracking C&Q schedule and establishing interdependencies between different systems for smooth execution meeting timelines.

Involved in Process Engineering and design reviews of manufacturing Equipment and preparing Validation plans, protocols and reports that support the qualification and Validation of systems.

Involved in detailed FAT testing of various Equipment/ manufacturing skids and meeting Client expectations with minimum to no deviations as per client requirement.