Technical Writer - Pharma

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

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

Hubot, Inc. (CDMO)

draft, revise, and approve

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

• PHARMACEUTICAL EXPERIENCE MANDATORY

• 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.

For Staffing & Recruitment Agencies

Hubot, Inc. works with preferred recruitment agencies under approved terms and conditions