The Technical Writer will support pharmaceutical validation activities by preparing, reviewing, and maintaining high‑quality validation documentation in compliance with GMP, data integrity, and regulatory requirements. The role focuses on Kneat‑based documentation, protocol preparation, execution review, and summary reporting.
Responsibilities
Documentation & Writing
- Draft, edit, and finalize validation protocols, execution summaries, and final reports using Kneat software
- Prepare structured documentation such as IQ/OQ/PQ summaries, qualification reports, and validation deliverables
- Ensure documentation follows Good Documentation Practices (GDP) and site‑specific SOPs
Review & Compliance
- Review Kneat execution entries for accuracy, completeness, and compliance
- Support pre‑ and post‑execution documentation reviews
- Ensure all validation documents meet regulatory requirements (e.g. GMP, data integrity, audit readiness)
Collaboration & Support
- Work closely with Validation Engineers, QA, and Project Teams to ensure documentation aligns with executed activities
- Track documentation status, revisions, and approvals
- Support audit and inspection readiness through well‑maintained documentation
Qualifications
- Diploma or Degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related field
- Hands‑on experience with Kneat documentation system
- Experience writing or supporting validation protocols and reports
- Strong understanding of GMP and Good Documentation Practices (GDP)
- Familiarity with validation lifecycle documentation
