Technical Writer

Job Responsibilities:

• Utilize advanced technical writing methods to produce documentation that is clear, concise, and thorough.
• Create and maintain technical documents including Standard Operating Procedures (SOPs) for facilities and equipment, batch records, specifications, and training materials.
• Lead and oversee change controls to implement new procedures and update existing documentation and SOPs for product launches.
• Participate in process and equipment testing to gain a comprehensive understanding of the systems being documented.
• Manage deviations, Corrective and Preventive Actions (CAPAs), change controls, document updates, and training assignments to adhere to quality system standards and deadlines.
• Collaborate with operations, R&D, and quality teams to fulfill all documentation requirements for projects.
• Ensure compliance with US and international regulatory standards and guidelines (e.g., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP).

Qualifications:

• Bachelor’s degree or equivalent professional experience.
• At least 3 years of relevant experience.
• Excellent English communication skills, including proficiency in grammar and composition.
• Deep understanding of GMP/cGMP regulations.
• Exceptional written and verbal communication abilities, with experience working in cross-functional teams.
• Strong time management skills and meticulous attention to detail.
• Proven capacity to manage multiple projects in a dynamic, professional environment.
• Ability to work independently as well as part of a team.
• Competent in reading, understanding, and following work instructions accurately and safely.
• Skilled in Microsoft Word, PowerPoint, and Excel.