Executive, QC Technical Writer

Prepare, review, and update QC documents including SOPs, specifications, test methods, protocols, reports, and quality records. Ensure documentation complies with GMP, regulatory guidelines, and internal quality systems. Collaborate with QC analysts, QA teams, and cross-functional departments to collect technical information and create clear documentation. Maintain document control processes, including version management, revisions, and archival activities. Initiate and evaluate the change control. Perform Monograph Evolution. Support audits and regulatory inspections by providing required documentation and records. Identify documentation gaps and recommend improvements to enhance compliance and efficiency.

• Seniority: Mid Level
• Languages: English