VP; QA, Compliance and Software Validations
Shilpa Desai is VP; QA, Compliance and Software Validations and is responsible for quality of products, processes and documentation.
Sarjen extensively works on software development and implementation of regulatory compliant software solutions in Pharmaceuticals and Life Sciences domains. Ms. Desai and her team handle the key portfolio of handling computer system validation projects as per various regulatory guidelines – part 11 compliance (US FDA’s 21 CFR part 11, EU’s Annex 11) for electronic records and signatures recommended per GAMP5 - GDPR and HIPAA compliant.
She has attended number of workshops and seminars in regulatory domain including many on GAMP5 and risk based CSV.
She and her team handle Validation and Data Integrity services taking up projects of software validations, Consultation of understanding of GAMP5 guided risk based CSV, CSV project and project management, conduct Training sessions of CSV topics, etc.
As head of Quality Assurance, she is responsible for devising and implementing quality strategy and handle customer/vendor audits for quality and processes.
She is an accomplished orator and has been speaker at number of events - CpHI conference or CSV related symposia and has spoken on various subjects of regulatory compliance, risk based software validations, etc. She has been involved in several Training programmes at Sarjen (in-house) and even at several Clients’ on myriad subjects.
She has a keen sense of color ‘n design which helps Sarjen’s Graphics studio in designing and conceiving, elaborating on the storyboard.
She is a keen storyteller and has conducted company-wide sessions on Business Storytelling.
She has worked with Sarjen since 1999 with an overall experience of over 25 years.
Prior to Sarjen, she has worked with Division of Molecular Endocrinology, The Gujarat Cancer and Research Institute, where she was involved in the endocrinological aspect and analyses of significance of several biochemical/other tumour markers including role of various hormones, hormone receptors, etc. in different malignancies.
She has Bachelor’s and Master’s degree in Microbiology specialising in Industrial and Medical Microbiology from Gujarat University, Ahmedabad, India.