Technical Writer
Core
Lead and execute Quality Management System (QMS) processes, including audits, inspections, and data validation to ensure compliance with GxP regulations.
Role type
Senior Quality Assurance Specialist (Clinical/Lab)
Builds
Quality management strategies, corrective action plans, and compliant documentation for client and regulatory programs.
Domain
Life Sciences / Clinical Quality Assurance / GxP
Deliverable
client delivery | dashboards & analysis
Required skills
GxP compliance, audit leadership, root cause analysis, batch record review, data validation, policy development, training delivery, risk assessment
Preferred skills
Trackwise system experience, vendor management, regulatory inspection preparation
Technologies
Trackwise
Responsibilities
Lead and attend inter-departmental meetings to develop QMS strategies; Represent the department in client and regulatory inspections/audits; Review complex batch records, lab investigations, and analytical reports for accuracy and completeness; Provide training for department and laboratory staff; Manage set up and filing of documents; Mentor junior team members.
Seniority
Senior, hands-on IC