Pooja
M.Pharm (Pharmacology) professional with 1.5+ years of experience in Quality Assurance, GMP compliance, and regulatory documentation
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About
M.Pharm (Pharmacology) professional with 1.5+ years of experience in Quality Assurance, GMP compliance, and regulatory documentation. Experienced in SOPs, SMF, VMP, BMR, BPR, MFR, URS, CAPA, validation documentation, document control, audit readiness, and regulatory compliance. Certified in Good Regulatory Practices (WHO-CDSCO-THSTI).
Currently building expertise in CTD/eCTD, ICH, USFDA, EMA, and Regulatory Information Management (RIM). Seeking an entry-level Global Regulatory Affairs Associate role.
Experience
Senior Associate - KP Pharmaffaires LLP
(2024-11 - 2025-05)
- Prepared/reviewed SOPs, SMF, VMP, MFR, BMR, BPR, URS and validation documents.
- Supported document lifecycle management, Schedule M compliance, audit readiness, client coordination, qualification/validation documentation and technical presentations.
Quality Assurance Executive - Belco Pharma
(2020-11 - 2021-11)
- Performed IPQA activities, line clearance, batch monitoring, BMR/BPR review, deviation investigation, CAPA, change control support, GMP/GDP compliance and internal audit support.
Education
M.Pharm - Pharmacology - GJUST Hisar (2020)
B.Pharm - Himachal Pradesh Technical University (2018)
