Technical Writer

Technical Writer – Quality & Manufacturing Documentation (India, supporting U.S. Operations)

Mumbai, India | Full-Time | On-site (with U.S. overlap)

Hubot, Inc. (CDMO)
— a fast-growing contract development and manufacturing organization specializing in
liquid and aerosol
filling for personal care and pharmaceutical brands — is hiring a
Technical Writer
to support our
U.S. operations
. This role owns the authoring, editing, and
QA-grade
review of production and quality documentation, ensuring our records are
clear, compliant, right-first-time
, and ready for release.

You will collaborate daily with U.S. Quality, Manufacturing, R&D, and Supply Chain teams to
draft, revise, and approve
specifications, batch records, SOPs/WIs, process flows, annual product reviews (APR/PQR), and release documentation — operating within Hubot's
Quality Management System (QMS)
and Good Documentation Practices (
GDP
).

What You'll Do

Production & Quality Documentation

• Draft, edit, and
  peer review
  batch production records (BPR/BMR), packaging records, and line logs to GDP standards
• Prepare and maintain
  raw material, packaging, in-process, and finished product specifications
  ; manage redlines and revision history
• Compile
  product release packages
  ; verify completeness vs. specifications, CoA/CoC, deviations/CAPA, and test results;
  sign off
  as authorized under QMS delegation
• Create and maintain
  APR/PQR
  reports (trend OOS/OOT, deviations, complaints, stability, and yield/cycle-time metrics)

QMS & Controlled Documents

• Author, revise, route, and
  approve
  controlled documents (SOPs, WIs, forms, process maps) through electronic DMS/eQMS
• Ensure change control records (rationale, impact assessment, training, effectiveness checks) are complete and audit-ready
• Support
  document readiness for audits
  (internal, client, and regulatory); retrieve records and respond to document requests

Cross-Functional Partnering (U.S.–India)

• Work closely with U.S. QA/QC, Manufacturing, Engineering, Validation, and Regulatory teams; align on templates, styles, and release criteria
• Standardize document templates and
  visual process flows
  (swimlanes, SIPOC, RACI) to simplify training and execution
• Support
  new product introductions
  by drafting master records/specs and routing through change control

Compliance & Standards

• Apply
  cGMP/GDP
  and relevant standards/regulations:
  21 CFR 210/211
  , 21 CFR 111/820 (as applicable),
  ISO 9001/13485
  ,
  ISO 22716
  , ICH Q7/Q10 terminology
• Uphold
  data integrity (ALCOA+)
  principles; ensure every record is attributable, legible, contemporaneous, original, accurate

Tools

• Work within eQMS/DMS (e.g., MasterControl, Veeva, TrackWise, ETQ, or similar); collaborate in LIMS/ERP contexts; advanced
  MS Word/Excel/PowerPoint
  , Adobe Acrobat; Visio/Lucidchart for flows

Qualifications

• Education:
  Bachelor's in Life Sciences, Pharmacy, Engineering, Technical Communication, or related discipline
• Experience:
  5+ years
  in
  GMP technical writing / document control / QA documentation
  within pharmaceutical, personal care/OTC, medical device, or CDMO settings
• Demonstrated Strengths:
• Expert command of
  GDP
  and controlled document lifecycles (creation → review → approval → issuance → archival)
• Proven experience drafting
  batch records, specifications, SOPs/WIs
  , APR/PQR, and
  release documentation
• Familiarity with
  change control, deviations/CAPA, complaints, OOS/OOT
  record structures
• Excellent written English; meticulous attention to detail; comfort editing for clarity, accuracy, and consistency
• Success working
  cross-time-zone
  with U.S. teams; strong ownership, responsiveness, and follow-through
• Nice to Have:
  Exposure to validation documentation (IQ/OQ/PQ), stability protocols/reports, labeling/IFU control, and training curricula

Schedule & Location

• Mumbai on-site role with
  regular U.S. time-zone overlap
  (evening India hours as needed for reviews/meetings)

Success Metrics (first 6–12 months)

• Right-First-Time
  documentation ≥
  98%
  (zero critical GDP errors)
• On-time routing/approval
  ≥
  95%
  per SLA
• Document cycle time
  reduced by
  20–30%
  via templates and standardized flows
• Audit support:
  zero document-related major/critical findings

Why Join Hubot?

• Sustained Growth:
  Hubot grows
  25–30% YoY
  , with strong momentum
  through 2030
• Employer Reputation:
  4.8
  Glassdoor |
  4.6
  Indeed |
  95%
  recommend | Work Wellbeing
  78
• Impact & Visibility:
  Your work enables product release and regulatory confidence across the U.S. network
• Career Path:
  Senior Technical Writer → Documentation Lead → Quality Systems/Regulatory Documentation

Benefits

Competitive compensation; health benefits; paid time off; learning & development; opportunities to collaborate with U.S. stakeholders and broaden your QA/Regulatory skill set.

Hubot, Inc.
is an
Equal Employment Opportunity / Affirmative Action Employer
.

For Staffing & Recruitment Agencies

We do not accept unsolicited CVs or applications.
Hubot, Inc. works with preferred recruitment agencies under approved terms and conditions
. By contacting Hubot or submitting candidates, you agree to operate under Hubot's standard terms.