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Vidushi Singh

Compliance Specialist (CAPA, Change Control, Deviations) | Veeva Vault DMS | McKinsey Forward | Biopharma Compliance & Consulting

India

4+ years of work experience

Biocon Biologics
Apr 20267 mosPresent

Manage CAPA lifecycle from initiation through closure, ensuring root-cause investigations meet GMP documentation standards. Lead Change Control assessments and cross-functional coordination for process/system changes. Process deviation records within Veeva Vault DMS, ensuring timely closure and audit-readiness. Background in downstream biologics manufacturing (purification, filtration, API isolation), providing operational context to compliance decisions.
Biocon Biologics
Aug 20242 yrs 3 mosPresent

Downstream processing: purification, filtration, and isolation of APIs Analytical techniques: HPLC, biochemical characterization, data interpretation Process optimization and troubleshooting for yield and quality improvement Cross-functional collaboration with manufacturing teams Documentation and adherence to GMP/GLP standards Data-driven problem solving and process improvement mindset
ProfCess
Aug 20201 yr 3 mosOct 2021

I Researched and wrote blog articles on relevant industry topics Assisted in creating and structuring website content for improved user experience Collaborated with teams to align content with branding and communication goals Edited and refined content to ensure clarity, accuracy, and engagement Supported content strategy and digital presence initiatives
Aug 20205 mosDec 2020

Sep 20192 yrs 8 mosApr 2022

Conducted workshops and seminars Managed events and national science day in college Enthusiastically participated in events and was team lead for different domains

Vidushi’s AI Stack

deepmind
deepmind

Education

Indian Institute of Science (IISc)

Master's Thesis, Plant Molecular Biology and Genetics

Indian Institute of Science (IISc)

20242024
Vellore Institute of Technology

Masters of science, Microbiology and Applied sciences

Vellore Institute of Technology

20222 yrs2024

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Headline

Compliance Specialist (CAPA, Change Control, Deviations) | Veeva Vault DMS | McKinsey Forward | Biopharma Compliance & Consulting

About

Compliance professional in biopharmaceutical manufacturing, currently managing CAPA, Change Control, and Deviation processes within Veeva Vault DMS at Biocon Biologics. Background spans downstream biologics manufacturing (purification, filtration, API isolation) into Quality/Compliance, giving me hands-on grounding in both GMP operations and the compliance frameworks that govern them. Research foundation includes a Master's dissertation at the Indian Institute of Science (IISc) in plant molecular biology and genetics, alongside an M.Sc. in Microbiology and Applied Sciences — bringing strong analytical and technical writing capability to compliance documentation and root-cause investigations. Completed the McKinsey Forward Program, building structured problem-solving and business strategy skills alongside deep technical compliance expertise. Actively seeking compliance, quality, or consulting roles in biopharma sector.

Location

India

AI stack

deepmind

Work experience

Compliance Executive (QMS) at Biocon Biologics, Apr 2026 - Present · 7 mos, Manage CAPA lifecycle from initiation through closure, ensuring root-cause investigations meet GMP documentation standards. Lead Change Control assessments and cross-functional coordination for process/system changes. Process deviation records within Veeva Vault DMS, ensuring timely closure and audit-readiness. Background in downstream biologics manufacturing (purification, filtration, API isolation), providing operational context to compliance decisions.

Operations Executive at Biocon Biologics, Aug 2024 - Present · 2 yrs 3 mos, Downstream processing: purification, filtration, and isolation of APIs Analytical techniques: HPLC, biochemical characterization, data interpretation Process optimization and troubleshooting for yield and quality improvement Cross-functional collaboration with manufacturing teams Documentation and adherence to GMP/GLP standards Data-driven problem solving and process improvement mindset

Content Writer and Team Leader at ProfCess, Aug 2020 - Oct 2021 · 1 yr 3 mos, I Researched and wrote blog articles on relevant industry topics Assisted in creating and structuring website content for improved user experience Collaborated with teams to align content with branding and communication goals Edited and refined content to ensure clarity, accuracy, and engagement Supported content strategy and digital presence initiatives

Marketing Intern at Unleash your passion, Aug 2020 - Dec 2020 · 5 mos

Co-Founder at BiOrigin, Sep 2019 - Apr 2022 · 2 yrs 8 mos, Conducted workshops and seminars Managed events and national science day in college Enthusiastically participated in events and was team lead for different domains

Education

Master's Thesis, Plant Molecular Biology and Genetics, Indian Institute of Science (IISc)

Masters of science, Microbiology and Applied sciences, Vellore Institute of Technology