Document Control Specialist
17 hours ago
Technical Writer / Document Control Specialist (Pharma) – India based → U.S. SupportMumbai, India | Full-Time | On-Site | U.S. OverlapTurn complex manufacturing and quality work into clear, compliant, releasable records.Hubot, Inc. (CDMO) — a leading developer and manufacturer of aerosols, liquids, tubes, and suppositories for personal care and pharmaceutical brands is hiring a Technical Writer / Document Control Specialist to support our U.S. manufacturing and quality operations. You’ll author, review, and maintain GMP documentation across production, QA, validation, and regulatory teams to ensure inspection readiness and seamless batch release.Why Join Hubot?25–30% YoY growth forecast through 20304.8 Glassdoor | 4.7 Indeed | 95% recommend | Well-being 79Impact that counts: Your documentation drives batch release and regulatory compliance in the U.S.Global collaboration: Daily partnership with U.S. QA, Manufacturing, Validation, and Regulatory teamsCareer path: Technical Writer → Documentation Lead → Quality Systems / Regulatory DocumentationWhat You’ll Do- Draft, edit, and route GMP-controlled documents including SOPs, WIs, Specifications, BMR/BPRs, and Validation Protocols/Reports. - Maintain the full document lifecycle within the eQMS — issuance, routing, review, approval, and archival. - Review and format production and QA documentation for GDP and ALCOA+ compliance prior to release. - Compile and verify product release packages against specifications, CoA/CoC, deviations, CAPAs, and change controls. - Support APR/PQR preparation by trending OOS/OOT, deviation, and stability data. - Manage document templates and version control for consistency across departments. - Assist in internal and external audit preparation by ensuring complete, retrievable documentation. - Communicate and implement documentation updates across global QA and manufacturing teams.Who You Are (Pharma-First)- 5+ years in GMP technical writing or document control within pharma, biopharma, OTC, or CDMO environments. - Proficient in FDA 21 CFR 210/211, cGMP/GDP, ALCOA+, and change control processes. - Experienced with eQMS/DMS systems (TrackWise, MasterControl, SAP DMS, or equivalent). - Strong command of written English; capable of preparing documents to inspection-ready U.S. standards. - Detail-oriented, organized, and comfortable working with U.S. teams in overlapping hours.Success Metrics- ≥ 98 % Right-First-Time (RFT) document accuracy - ≥ 95 % on-time routing and approval vs SLA - Zero critical GDP or audit findings related to documentation - ≥ 20 % reduction in document cycle time within six monthsWhy It MattersYour documentation enables every Hubot batch released in the U.S. to be fully traceable, compliant, and audit-ready.Precision in writing is precision in manufacturing and at Hubot, both define excellence.Ready to build the records that power our products?Apply via LinkedIn or message us directly.For more information, visit www.hubot.us#TechnicalWriter #DocumentControl #GMP #GDP #ALCOA #QMS #CDMO #BatchRecords #PharmaJobs #MumbaiJobs #GlobalQuality #RegulatoryCompliance
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