Deviations Technical Writer

Global Compliance Partners is seeking an experienced Deviation Technical Writer to support our quality and compliance initiatives within a regulated GMP manufacturing environment. This role is ideal for someone who thrives under tight timelines, has a sharp eye for detail, and can translate complex investigations into clear, regulatory-compliant documentation. The ideal candidate will work cross-functionally with subject matter experts and quality stakeholders to ensure timely closure of deviations, root cause identification, and robust CAPA development. The position requires travel to the client site for the first 3 to 4 weeks, with all travel and accommodation expenses covered.

After this initial ramp-up period, the majority of the work can be performed remotely.

Responsibilities• Draft and revise deviation investigation reports based on SME input and supporting documentation• Ensure reports are aligned with internal SOPs and applicable regulatory guidelines (FDA, EU GMP)• Collaborate with cross-functional teams including Quality, Manufacturing, and Investigations to gather necessary information and resolve open items• Identify root causes and contribute to robust CAPA development where applicable• Prioritize workload to ensure all assigned deviations are closed within the project timelineQualifications• Minimum 3 years of experience authoring deviation reports in a regulated GMP environment• Solid understanding of deviation lifecycle, root cause analysis methodologies, and CAPA justification• Excellent technical writing and analytical skills with the ability to interpret and summarize complex information clearly• Proficiency with QMS platforms such as TrackWise or Veeva is preferred.