QA Document Control Administrator

4 days ago


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

Technical Writer / Document Control Specialist (Pharma) – India based → U.Mumbai, India | Full-Time | On-Site | U.Turn complex manufacturing and quality work into clear, compliant, releasable records. 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. 4.8 Glassdoor | 4.7 Indeed | 95% recommend | Well-being 79 #Your documentation drives batch release and regulatory compliance in the U.QA, Manufacturing, Validation, and Regulatory teams #Technical Writer → Documentation Lead → Quality Systems / Regulatory Documentation 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. 5+ years in GMP technical writing or document control within pharma, biopharma, OTC, or CDMO environments. ~ Experienced with eQMS/DMS systems (TrackWise, MasterControl, SAP DMS, or equivalent). ~ Strong command of written English; capable of preparing documents to inspection-ready U.Precision in writing is precision in manufacturing and at Hubot, both define excellence. Apply via LinkedIn or message us directly. TechnicalWriter #DocumentControl #GMP #GDP #ALCOA #QMS #CDMO #BatchRecords #PharmaJobs #MumbaiJobs #GlobalQuality #RegulatoryCompliance


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