- 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.