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Pharmaceutical Documentation Specialist

Pharmaceutical Documentation Specialist

Hubot | Tri Pac, Inc. CDMORepublic Of India, IN
17 days ago
Job description

Technical Writer / Document Control Specialist (Pharma) – India → U.S. Support

📍 Mumbai, India | Full-Time | On-site | U.S. Overlap

Turn 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 2030

🌟 4.8 Glassdoor | 4.7 Indeed | 95% recommend | Wellbeing 79

🧭 Impact that counts : Your documents enable batch release and 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 Docs

What 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 retrieval

    • Who 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 overlap

    Success Metrics

  • ≥98% RFT docs (zero critical GDP errors)
  • ≥95% on-time routing / approval vs. SLA
  • 20–30% faster cycle times via standardization

    • Ready 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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