Job description

1. Location: Poland (remote)
2. Project language: English
3. Project length: Initial 6 months contract with potential prolongations.
4. Start: Mid-August 2023
5. Assignment type: B2B - up to 130-140 zl/h
6. Workload: Full time
7. Deliverables: System-specific Data Integrity Compliance Reports, SOP updates, and remediation plans.

Introduction & Summary:

We are looking for a proficient Technical Writer with 1–2 years of experience in regulated environments to support our Data Integrity Program for a pharmaceutical client. The successful candidate will demonstrate strong written English skills and the ability to create clear documentation, including system-specific compliance reports and SOPs. This role is critical for ensuring compliance and adherence to industry standards.

Main Responsibilities:

The Technical Writer will be responsible for the creation and management of essential documentation in a GMP setting.

1. Create compliance reports and update standard operating procedures (SOPs).
2. Document compliance gaps and proposed remediation actions for approximately 50 GMP-critical systems.
3. Review and analyze validation documentation and audit findings.
4. Ensure clarity and accuracy in all technical documentation.
5. Follow predefined templates and documentation structures to maintain consistency.
6. Collaborate with cross-functional teams to gather necessary information.

Key Requirements:

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

Nice to Have:

1. Experience in the pharmaceutical industry beyond GMP.
2. Familiarity with GAMP5 guidelines.
3. Experience with data integrity audits.

Other Details:

Project Context: This role is part of Phase 2 of a Data Integrity Program in a GMP environment, focused on addressing compliance gaps and ensuring data integrity across critical systems.