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Умения

Quality Assurance QMS IPQA CAPA Deviation Management Change Control Regulatory Compliance GMP Audits Document Control SOP Development Cross‑functional Coordination Sample Management Risk Assessment Audit Preparation Continuous Improvement

Опит

QA/QMS and IPQA Officer

Renown Pharmaceuticals Pvt. Ltd.

2024-11 -

Maintain control samples and records for collection, storage and destruction while ensuring compliance with QMS procedures. Coordinate cross‑functional teams for deviation, change control, CAPA and market complaint handling. Prepare and review annual product quality reports, BMR/BPR documents and regulatory submissions. Lead audit preparation and support WHO and third‑party GMP inspections, achieving no critical observations. Develop and update SOPs, manage documentation, and oversee IPQA activities across warehouse, manufacturing and packaging lines.

Образование

B.Pharm, Divine International Group of Institutions, Gwalior (2024)

Езици

English

fluent

Hindi