Technical Writer I (5625794)
• Ensure timely and efficient creation/review of Label & Pack documents: standard operating procedures, batch records, technical protocols and reports, etc.
• Contribute understanding of Good Documentation Practices (GDP) and Current Good Manufacturing Practices (CGMP), analytical skills, and interpretation of the information to be captured on the document
• Ensure a consistent style of presentation of Label and Pack documents to maintain quality and ease of review
• Coordinate with Engineering on tasks for validation qualification, preventative maintenance and re-qualification program processes
• Act as subject matter expert (SME) for documentation with Development and Training (D&T) , and provide input in cross-functional teams, including during Quality Assurance (QA) and Quality Control (QC).
• Help develop OJT's for proficiency of L&P staff with respect to process knowledge and critical parameters; ensure understanding and interpretation of results from tools deployed in the process
• Support readiness for regulatory inspections and compliance audits.
• Assess current documentations for Error Reduction updates and ensure timely revision and review of periodic review
• Support development of junior analysts through mentoring
• Coordinate CAPA tasks with document changes for timely closure of compliance events with deviations investigators
• Revise standard operating procedures as needed
• sPractice safe work habits and adhere to Sanofi's safety procedures and guideline
Skills:
• Minimum of 5 years of experience in a regulated environment
• Previous experience with technical writing for manufacturing in a regulated environment
• Use of documentation controls systems to manage workflow
Education: Bachelor's degree in a related discipline
For more information, please contact
Akriti Gupta
973.967.3409