Technical Writer

Experience: 5–8 Years Responsibilities Author, review, and maintain DTMS and GxP validation documentation in accordance with project and regulatory requirements. Prepare and update specifications, traceability matrices, test documentation, validation reports, and release documentation. Ensure documentation complies with GxP, Good Documentation Practices (GDP), ALCOA+, Quality Management System (QMS), and applicable quality processes. Coordinate with Business, Technical, QA, Validation, and Quality teams to incorporate review feedback and obtain document approvals. Maintain document version control, support change control activities, and ensure documentation reflects approved releases and system changes. Support quality reviews, audit and inspection readiness, and continuous improvement of documentation processes. Required Skills 5–8 years of experience in GxP documentation, Computer System Validation (CSV), or quality documentation within the Life Sciences/Pharma industry. Strong knowledge of GxP, GDP, ALCOA+, GAMP 5, Quality Management Systems (QMS), and document control processes. Experience working with quality processes, document review/approval workflows, and change management. Excellent technical writing, document review, and stakeholder coordination skills.