Quality Assurance Technical Writer

2 days ago

Mumbai, India Hubot | Tri Pac, Inc. CDMO Full time

Technical Writer / Document Control Specialist (Pharma) – India → U.Mumbai, India | Full-Time | On-site | U.Turn complex manufacturing and quality work into clear, compliant, releasable records . CDMO) is hiring a pharma Technical Writer / Document Control Specialist to support our U.S. operations —authoring and QA-grade reviewing BMR/BPR, Specifications, SOP/WI, APR/PQR , and Product Release packages inside a validated eQMS . 8 Glassdoor | 4.7 Indeed | 95% recommend | Wellbeing 79 #Your documents enable batch release and audit readiness in the U.QA/Manufacturing/Validation/Regulatory #Senior Writer → Documentation Lead → Quality Systems/Regulatory Docs Draft, edit, and review BMR/BPR and packaging records to GDP standards Build APR/PQR trend reports (OOS/OOT, deviations, complaints, stability, yields) route via eQMS/DMS with full change control Support audit/inspection readiness and rapid document retrieval 5+ years in GMP technical writing / document control within pharma/biopharma/OTC/device/CDMO ~ Comfortable in eQMS/DMS (DOT Compliance/Track Wise), ERP/LIMS context ~ Exceptional written English; TechnicalWriter #DocumentControl #GMP #GDP #ALCOA #QMS #CDMO #BatchRecords #PharmaJobs #MumbaiJobs

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