Open to opportunities

Apar Sharma

@aparsharma

Message

Computer System Validation specialist focused on GAMP 5, 21 CFR Part 11, and ALCOA+ data integrity.

Lithuania

Message

What I'm looking for

I’m looking to join a pharmaceutical or life sciences organisation as a CSV Specialist/Validation Analyst—delivering GAMP 5 lifecycle validation, 21 CFR Part 11 & EU Annex 11 compliance, data integrity governance, and risk-based protocols with strong project leadership.

I’m a pharmaceutical professional with 9 years of industry experience focused exclusively on Computer System Validation (CSV), building end-to-end GAMP 5 lifecycle validation packages—from IQ/OQ/PQ through requirements traceability and final validation summary reports. I drive compliance with 21 CFR Part 11 and EU GMP Annex 11, including ERES/e-signature controls, audit trail design and review, RBAC user access management, and ALCOA+ data integrity governance.

I’ve led and authored URS/FS/DS/RTM/VMP/VP and risk-based protocols, including cloud/SaaS validation (EMA 2023), and I manage deviation and CAPA workflows using structured root-cause approaches (FMEA/5-Why). With a PMP certification and prior 6 years in Analytical Research & Development, I blend regulated-lab execution with strong project leadership—validated across major analytical platforms and tools like MassLynx, Agilent OpenLab CDS, Shimadzu LabSolutions, SCIEX Analyst, plus LIMS/ELN environments.

Experience

Work history, roles, and key accomplishments

CSV Specialist

Teva Pharmaceuticals India Pvt. Ltd.

Jul 2020 - Sep 2025 (5 years 2 months)

Led GAMP 5 lifecycle validation for multiple analytical platforms, authoring URS/FS/DS, IQ/OQ/PQ protocols and validation summary reports to ensure 21 CFR Part 11 and EU GMP Annex 11 compliance. Managed deviation/change control and CAPA, performed e-records/e-signatures (ERES) and audit trail scope assessments, and oversaw RBAC user access validation and periodic review activities.

EU GMP Annex 11 IQ OQ PQ Validation ERES & Audit Trail Deviations And CAPA QMS Tools (EDMS Trackwise HP ALM)

Senior Research Scientist II

Fresenius Kabi Oncology Ltd.

Jan 2015 - Jul 2020 (5 years 6 months)

Supported regulated analytical R&D activities including preparation of specifications and GxP documentation (SOPs/STPs) and participation in installation and qualification activities for analytical instruments and associated applications. Administered user access and segregation-of-duties controls across instrument software to support compliance with data integrity expectations in GMP laboratory e

GxP Documentation (SOP STP)Regulated Laboratory Execution Analytical Instrumentation Support

Research Associate

Mankind Research Center

Feb 2013 - Sep 2014 (1 year 7 months)

Contributed to analytical research and development in regulated laboratory settings by preparing and maintaining compliance-oriented specifications, SOPs, and STPs. Assisted with instrument and application readiness activities, including installation/qualification work and user/access administration for analytical systems.

Analytical Development STP URS Style Requirements Support Installation & Qualification Support Analytical Instrument Support

Research Associate

Ind-Swift Laboratories Limited

Jul 2010 - Jan 2013 (2 years 6 months)

Performed early-stage analytical research and development in GMP-regulated contexts, including documentation preparation (specifications, SOPs, and STPs) and support for regulated laboratory execution. Worked on instrument/application setup activities and maintained controlled documentation aligned to data integrity expectations.

Analytical Development GxP Documentation (SOP STP)Specifications And Acceptance Criteria Support Regulated Laboratory Work Instrument Application Support Data Integrity Document Control User Access Coordination