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Aravind Kumar V

Aravind Kumar V

REGULATORY AFFAIRS & QUALITY ASSURANCE EXECUTIVE — FRESHER

Talent
BengaluruMember since April 23, 2026
GMP/ cGMP and GDP complianceBasic awareness of CTD/eCTD process workflowAudit readinessALCOA+ and data integrity principlesSOP writing, review and document control
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GMP/ cGMP and GDP complianceBasic awareness of CTD/eCTD process workflowAudit readinessALCOA+ and data integrity principlesSOP writing, review and document control

About

Motivated M.Pharm (QA) fresher with foundational exposure to sterile injectable validation, cGMP compliance, ALCOA+ data integrity, and regulatory documentation — including basic awareness of CMC regulatory documentation, ICH CTD/eCTD modules, small molecule pharmaceutical quality systems and WHO-GMP standards. Eager to learn and contribute meaningfully to IPQA, Validation, QMS, and Regulatory Affairs roles, upholding the highest standards of pharmaceutical quality and patient safety.

Experience

Project internship at Dr. Reddy's laboratories (2025-09 – 2026-03)

  • Delivered end-to-end IQ/OQ/PQ for a PFS isolator system — HVAC, pressure differential, glove integrity, and media fill studies — ensuring ALCOA+ and GDP compliance with 21 CFR Part 211, supporting CMC-relevant manufacturing quality documentation and compliance records aligned to global regulatory standards.

Industrial trainee at Allastir Private Limited (2023-05 – 2023-05)

  • Completed 15-day internship executing cGMP-compliant raw material dispensing, shelf life and label compliance verification, and visual inspection of finished dosage forms

Industrial trainee at Goodman Pharmaceuticals (2023-05 – 2023-05)

  • Completed 15-day internship reviewing packaging-related BMR and MFR documents across solid dosage lines — detected and escalated 1 documentation discrepancy during BMR review, upholding GDP and data integrity compliance.

Education

M pharmacy in Quality assurance – SRIHER (2026)

B pharmacy – SRIHER (2024)

HSC – National school (2020)

SSLC – National school (2018)

Skills

REGULATORY AFFAIRS & QUALITY ASSURANCE EXECUTIVEFRESHER

Reviews