Technical Writer

3 weeks ago

New Delhi, India Hubot | Tri Pac, Inc. CDMO Full time

Technical Writer / Document Control Specialist (Pharma) – India → U.S. SupportMumbai, India | Full-Time | On-site | U.S. OverlapTurn complex manufacturing and quality work into clear, compliant, releasable records. Hubot, Inc. (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.Why Join Hubot?25–30% YoY growth with momentum through 20304.8 Glassdoor | 4.7 Indeed | 95% recommend | Wellbeing 79Impact that counts: Your documents enable batch release and audit readiness in the U.S.Global collaboration: Daily partnership with U.S. QA/Manufacturing/Validation/RegulatoryCareer path: Senior Writer → Documentation Lead → Quality Systems/Regulatory DocsWhat You’ll Do- Draft, edit, and review BMR/BPR and packaging records to GDP standards - Create/maintain raw/pack/FG specifications; manage redlines and version control - Compile release packages; verify vs. specs, CoA/CoC, deviations/CAPA; sign off as authorized - Build APR/PQR trend reports (OOS/OOT, deviations, complaints, stability, yields) - Author/revise SOPs/WIs/forms/process flows; route via eQMS/DMS with full change control - Support audit/inspection readiness and rapid document retrievalWho You Are (Pharma-first)- 5+ years in GMP technical writing / document control within pharma/biopharma/OTC/device/CDMO - Fluent in 21 CFR 210/211, cGMP/GDP, ALCOA+, change control, deviations/CAPA, OOS/OOT - Comfortable in eQMS/DMS (DOT Compliance/Track Wise), ERP/LIMS context - Exceptional written English; meticulous editor; thrives with U.S. time-zone overlapSuccess Metrics- ≥98% RFT docs (zero critical GDP errors) - ≥95% on-time routing/approval vs. SLA - 20–30% faster cycle times via standardizationReady to write the records that release the products? Apply or message us directly.For a more detailed brief, visit www.hubot.us.#TechnicalWriter #DocumentControl #GMP #GDP #ALCOA #QMS #CDMO #BatchRecords #PharmaJobs #MumbaiJobs

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