Technical Writer

Other

-, Warszawa

emagine Polska

Full-time

B2B

Mid

Remote

Tech stack

English

B2

SOP

junior

system documentation

junior

ALCOA+

junior

21 CFR Part 11

junior

GMP

nice to have

Job description

• Location: Poland (remote)
• Project language: English
• Project length: 6 months contract + prolongations
• Start: mid August
• Duration: for start up to 6 month (start August 16)
• Assignment type: B2B
• Workload: Full time
• Deliverables: System-specific Data Integrity Compliance Reports, SOP updates, remediation plans.

Project Context:

Supporting Phase 2 of a Data Integrity Program for a pharmaceutical company (GMP environment, ALCOA+ principles, GAMP5). Writer will document compliance gaps and remediation actions across ~50 GMP-critical systems.

Profile Requirements (Essential):

• 1–2 years of experience as a Technical Writer in a regulated (preferably GMP) environment.
• Strong written English and ability to follow predefined templates and structures.
• Experience creating system documentation, SOPs, or compliance reports.
• Able to read and synthesize complex source materials (e.g. SOPs, validation docs, audit findings).
• Familiarity with ALCOA+ principles, 21 CFR Part 11, or data integrity concepts.
• Organized, structured, able to deliver high-quality documentation on time.

Published: 13.08.2025

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