Ravi Dhorajiya

Quality and Regulatory professional with 2 years of experience supporting GxP-compliant pharmaceutical and clinical operations through strong QA documentation, audit readiness, and compliance execution. Proficient in deviation management, CAPA, change control, batch record review (BMR/BPR), SOP development, and data integrity (ALCOA+) to ensure consistent quality outcomes. Knowledgeable in GCP, ICH guidelines, and 21 CFR Part 11 requirements, with hands-on exposure to internal audits and regulatory support activities.

Proficient in Veeva Vault QMS, TrackWise QMS, SAP, LIMS, and MS Office Suite.

Regulatory Affairs Intern - Biogen, USA - USA

(2026-01)

• Supported regulatory compliance activities across products by assisting with deviation documentation, change controls, and regulatory impact assessments, ensuring alignment with FDA, ICH, and GMP requirements across regulatory frameworks.
• Analyzed regulatory and quality data using Excel and internal regulatory systems, generating compliance summaries and trend analyses to support audit readiness, inspections, and ongoing regulatory surveillance for regulated product portfolios.
• Maintained and organized regulatory documentation repositories and quality metrics trackers, identifying process improvement opportunities and supporting cross-functional teams in prioritizing regulatory and compliance initiatives across therapeutic areas.

Quality Assurance Specialist - Fortis Healthcare, Gujarat, India - Gujarat, India

(2022-07 - 2023-12)

• Reviewed and maintained 150+ quality documents, including controlled forms, logs, and compliance records, ensuring alignment with GMP documentation practices and quality standards for audit readiness and compliance.
• Performed routine GMP floor rounds and process verification checks, identifying non-conformances early and supporting consistent compliance across operations with timely issue escalation tracking.
• Supported 15+ deviation investigations, performed root cause analysis (RCA), and assisted in implementing CAPA, improving the prevention of recurring quality events through corrective and preventive follow-up.
• Ensured 100+ equipment calibration/qualification records were complete and audit-ready, supporting validation compliance and regulated documentation requirements as per defined QA checklists.
• Managed 12–20 SOP control and revision workflows over 1 year, ensuring complete change history, version control accuracy, and QMS traceability to maintain document lifecycle integrity.
• Coordinated with 4+ cross-functional teams (Operations, Engineering, QC, Compliance) to support 6–10 quality improvements and corrective actions, helping meet GMP compliance requirements and audit expectations.
• Provided real-time QA oversight for 80–120 batch records/document sets across 1 year, improving right-first-time documentation, minimizing errors, and strengthening inspection readiness during internal checks.

Quality Assurance Intern - Fortis Healthcare, Gujarat, India - Gujarat, India

(2022-01 - 2022-06)

• Supported QMS documentation readiness for 40–60 controlled records by preparing, organizing, and maintaining documentation for QA review and 5–8 internal compliance checks under regulated quality system guidelines.
• Assisted in 2–3 internal audits by verifying 50–80 documents for completeness, traceability, and adherence to approved SOPs and controlled templates, ensuring inspection-ready audit files.
• Contributed to updating 5+ SOPs, ensuring compliance with revised standards, proper documentation control, and improved procedural consistency across departments and QA workflows.
• Monitored and documented 100+ equipment maintenance and calibration records, improving traceability and adherence to compliance requirements as per approved calibration schedules.
• Assisted in preparing documentation packs for quality reviews, ensuring accuracy, formatting compliance, and timely completion.

Master of Science - Regulatory Affairs - Northeastern University, Boston, MA (2024-01 - 2025-12)

Bachelor of Pharmacy - Pharmacy - Gujarat Technological University, Gujarat, India (2019-07 - 2023-07)