Shikha Raikundalia
Integrity
CSV Consultant
As a seasoned CSV (Computer System Validation) consultant, I bring a unique blend of expertise in biochemistry, regulatory affairs, and validation practices to the forefront of the pharmaceutical and biotech industries. With a career spanning across diverse sectors, I have consistently championed the integration of cutting-edge technologies while ensuring compliance with stringent regulatory standards.
My journey into the realm of CSV began with a foundation in Biochemistry and a Post-Grad in Biopharmaceutical Sciences. Having a solid background in clinical trials via translation of regulatory content for health authorities, I was provided with the opportunity to work for a biopharmaceutical CDMO, Genibet, providing me with a deep understanding of the intricacies of cGMP manufacturing services. Building upon this knowledge, I transitioned into a validation specialist role at Hovione, where I honed my skills as part of a multidisciplinary team validating critical systems and processes essential for drug manufacturing and quality assurance.
Recognizing the pivotal role of industry collaboration in driving excellence, I have been actively involved with ISPE (International Society for Pharmaceutical Engineering) as a volunteer and currently serve as the Chair of the GAMP (Good Automated Manufacturing Practice) Community of Practice in Portugal. In this capacity, I am dedicated to fostering knowledge exchange, best practices, and professional development opportunities for industry professionals navigating the complexities of CSV.
As a CSV consultant at Integrity, I am committed to leveraging my multifaceted background to empower organizations in achieving regulatory compliance and operational excellence. Whether navigating the validation requirements of complex IT systems or optimizing quality management processes, I am driven by a passion for innovation and a relentless pursuit of excellence in the Pharmaceutical Industry.
At the upcoming ISPE event, I look forward to sharing insights, experiences, and strategies for successful CSV implementation, and to engaging with fellow industry professionals in shaping the future of Pharmaceutical Engineering.
My journey into the realm of CSV began with a foundation in Biochemistry and a Post-Grad in Biopharmaceutical Sciences. Having a solid background in clinical trials via translation of regulatory content for health authorities, I was provided with the opportunity to work for a biopharmaceutical CDMO, Genibet, providing me with a deep understanding of the intricacies of cGMP manufacturing services. Building upon this knowledge, I transitioned into a validation specialist role at Hovione, where I honed my skills as part of a multidisciplinary team validating critical systems and processes essential for drug manufacturing and quality assurance.
Recognizing the pivotal role of industry collaboration in driving excellence, I have been actively involved with ISPE (International Society for Pharmaceutical Engineering) as a volunteer and currently serve as the Chair of the GAMP (Good Automated Manufacturing Practice) Community of Practice in Portugal. In this capacity, I am dedicated to fostering knowledge exchange, best practices, and professional development opportunities for industry professionals navigating the complexities of CSV.
As a CSV consultant at Integrity, I am committed to leveraging my multifaceted background to empower organizations in achieving regulatory compliance and operational excellence. Whether navigating the validation requirements of complex IT systems or optimizing quality management processes, I am driven by a passion for innovation and a relentless pursuit of excellence in the Pharmaceutical Industry.
At the upcoming ISPE event, I look forward to sharing insights, experiences, and strategies for successful CSV implementation, and to engaging with fellow industry professionals in shaping the future of Pharmaceutical Engineering.