Business and GxP compliant solutions, services by SarjenBusiness and GxP compliant solutions, services by SarjenBusiness and GxP compliant solutions, services by Sarjen

Shilpa Desai

Shilpa Desai is VP; QA, Compliance & Software Validations and is responsible for quality of products, processes and documentation.

Sarjen substantially works on software development and implementation of GxP compliant software solutions in Pharmaceuticals and Life Sciences domains. She and her team handle the key portfolio of handling computer system validation projects as per various regulatory guidelines – part 11 compliance for electronic records and electronic signatures (US FDA’s 21 CFR part 11, EU’s Annex 11, similar global others) recommended per GAMP5 – GDPR and HIPAA compliance. Emphasising on Testing (CSA) and Critical thinking and Risk assessment as per the latest edition of GAMP5.

She and her team work extensively supporting Sarjen’s business strategy of Cloud hosted solutions; pre-validated Cloud hosted GxP compliant solutions producing a comprehensive CSV document bundle.

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/CSA, CSV/CSA projects and project management, conduct Training sessions of concepts of CSV/CSA, etc.

As head of Quality Assurance, she is responsible for devising and implementing quality strategy and handle customer/vendor audits for quality and processes aided by her keen eye for detail.

She is an accomplished orator and was speaker at number of events – CpHI conferences 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); topics include CSV and 21 CFR part 11-Annex 11-GAMP5-Data Integrity-Data Governance, ISO 9001: 2015, ISO 9001: 2008 (formerly) 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, training people on HTML & SEO, Content development tools (website), ORM (Online Reputation Management) – SEO,
HR & Organizational policies, Marketing & BD, Promotional activities, Quality policy, etc.

She is a keen storyteller and has conducted company-wide sessions on Business Storytelling and promotions.

She has worked with Sarjen since 1999 (celebrating 25 years at Sarjen this year) and has an overall experience of over 31 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 degrees in Microbiology specialising in Industrial (Bachelor’s) and Medical (Master’s) Microbiology & Genetics from Gujarat University, Ahmedabad, India.

Book a Demo