Shamita Singh
@shamitasingh
I am a Validation & Documentation Specialist ensuring GxP-compliant, audit-ready systems.
IndiaWhat I'm looking for
I am a Validation & Documentation Specialist with over 10 years of experience in Computerized System Validation (CSV) and GxP-regulated environments, focused on maintaining data integrity and regulatory compliance.
I led CSV strategy across analytics and metadata platforms, developed and executed IQ/OQ/PQ protocols, authored SOPs, URS and FS documents, and managed version-controlled records in SharePoint to ensure audit readiness aligned with ALCOA+ principles.
I facilitate Agile ceremonies, perform risk assessments and collaborate with QA, IT and business teams to deliver compliant systems. I seek opportunities to lead validation initiatives, mentor teams, and drive documentation quality improvements in organizations committed to compliance and continuous improvement.
Experience
Work history, roles, and key accomplishments
Led CSV strategy for GxP-regulated analytics and metadata platforms; developed and executed validation plans (IQ/OQ/PQ), conducted risk assessments and audit readiness checks, and managed SharePoint version-controlled documentation to ensure data integrity and compliance.
Facilitated Agile ceremonies and managed validation deliverables each sprint; reviewed and updated SOPs, checklists, user guides, and test protocols aligned with GxP standards and supported audit preparations.
Documentation Specialist – Quality & Compliance
Jan 2017 - Jan 2021 (4 years)
Oversaw validation and compliance documentation for GxP client projects, drafted templates and guidelines, maintained document control per ALCOA+ principles, and implemented audit feedback to strengthen compliance practices.
Delivered training on documentation best practices, compliance, and business writing standards; developed guides and assessments to support audit-ready documentation processes.
Recruitment Analyst
IndiHire Consultants
Jan 2014 - Jan 2015 (1 year)
Managed candidate data accuracy and ensured compliance of recruitment documents to maintain reliable hiring records.
Education
Degrees, certifications, and relevant coursework
BVBanasthali Vidyapith
Master of Business Administration, Human Resource & Industrial Relations
2012 - 2014
Completed an MBA in Human Resource & Industrial Relations at Banasthali Vidyapith from 2012 to 2014.
AUAligarh Muslim University
Bachelor of Arts, Economics
2009 - 2012
Completed a Bachelor of Arts in Economics at Aligarh Muslim University from 2009 to 2012.
Availability
Location
IndiaAuthorized to work in
Job categories
Interested in hiring Shamita?
You can contact Shamita and 90k+ other talented remote workers on Himalayas.
Message ShamitaFind your dream job
Sign up now and join over 100,000 remote workers who receive personalized job alerts, curated job matches, and more for free!
