- Develop high-quality technical documents, including user manuals, SOPs, and protocols.
- Collaborate with cross-functional teams to ensure accurate and timely document delivery.
- Conduct computer system validations (CSV) and GXP documentation activities according to QMS requirements.
- Ensure compliance with regulatory guidelines by maintaining up-to-date knowledge of industry standards.
Job Requirements :
- 5-10 years of experience in Document Writer role or related field.
- Strong understanding of Positive Documentation Practices (GDP) principles and regulations (e.g., FDA).
- Proficiency in creating complex technical documents using standard templates and stylesheets.
- Experience with computer system validation (CSV) processes and GXP documentation tools.