Shweta Sharma is a seasoned Life Sciences Validation Manager at Tata Consultancy Services, bringing over 9.5 years of extensive experience in the IT industry, particularly in the realm of Computer System Validation (CSV). In her current role as Senior CSV Validation Lead, Shweta plays a...
Shweta Sharma is a seasoned Life Sciences Validation Manager at Tata Consultancy Services, bringing over 9.5 years of extensive experience in the IT industry, particularly in the realm of Computer System Validation (CSV). In her current role as Senior CSV Validation Lead, Shweta plays a pivotal role in ensuring compliance with stringent regulatory standards across various sectors, including pharmaceuticals and biotechnology. Her expertise encompasses a deep understanding of GxP regulations, FDA and EMA guidelines, and GAMP 5 principles, making her a key asset in navigating the complexities of regulatory IT compliance.
Shweta's responsibilities include providing comprehensive consultation and training to IT teams, ensuring that all computer systems meet the necessary compliance requirements. She is adept at implementing validation strategies across Agile, Waterfall, and Hybrid project models, which allows her to tailor approaches that best fit the unique needs of each project. Her proven experience in CAPA (Corrective and Preventive Actions) and deviation management further enhances her capability to uphold quality standards and mitigate risks associated with system validation.
Currently, Shweta is leading several high-impact projects that focus on optimizing validation processes and enhancing documentation practices. Her skills in project management and requirements analysis enable her to drive efficiency and foster collaboration among cross-functional teams. As a thought leader in the CSV domain, Shweta is committed to promoting best practices and ensuring that her organization remains at the forefront of compliance in the rapidly evolving landscape of life sciences technology.
