Technical Writer

3 days ago

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

Technical Writer / Document Control Specialist (Pharma) – India → U.S. Support Mumbai, India | Full-Time | On-site | U.S. OverlapTurn complex manufacturing and quality work intoclear, compliant, releasable records .Hubot, Inc. (CDMO)is hiring apharma Technical Writer / Document Control Specialistto support ourU.S. operations —authoring andQA-gradereviewingBMR/BPR, Specifications, SOP/WI, APR/PQR , andProduct Releasepackages inside a validatedeQMS .Why Join Hubot? 25–30% YoY growthwith momentumthrough 2030 4.8Glassdoor |4.7Indeed |95% recommend| Wellbeing79 Impact that counts:Your documents enablebatch releaseand audit readiness in the U.S. Global collaboration:Daily partnership with U.S. QA/Manufacturing/Validation/Regulatory Career path:Senior Writer → Documentation Lead → Quality Systems/Regulatory DocsWhat You’ll Do Draft, edit, and reviewBMR/BPRand packaging records toGDPstandards Create/maintainraw/pack/FG specifications ; manage redlines and version control Compilerelease packages ; verify vs. specs, CoA/CoC, deviations/CAPA;sign offas authorized BuildAPR/PQRtrend reports (OOS/OOT, deviations, complaints, stability, yields) Author/reviseSOPs/WIs/forms/process flows ; route viaeQMS/DMSwith full change control Supportaudit/inspection readinessand rapid document retrievalWho You Are (Pharma-first) 5+ yearsinGMP technical writing / document controlwithin pharma/biopharma/OTC/device/CDMO Fluent in21 CFR 210/211 ,cGMP/GDP ,ALCOA+ , change control, deviations/CAPA, OOS/OOT Comfortable ineQMS/DMS(DOT Compliance/Track Wise), ERP/LIMS context Exceptional written English; meticulous editor; thrives withU.S. time-zone overlapSuccess Metrics ≥98% RFTdocs (zero critical GDP errors) ≥95% on-timerouting/approval vs. SLA 20–30% fastercycle times via standardizationReady to write the records that release the products?Apply or message us directly. For a more detailed brief, visitwww.hubot.us.#TechnicalWriter #DocumentControl #GMP #GDP #ALCOA #QMS #CDMO #BatchRecords #PharmaJobs #MumbaiJobs

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