Technical Writer
Job Specification Technical Writer (SOP Development, Manufacturing Operations)
Role: Create, revise, and manage SOPs and technical documents for biopharma manufacturing operations.
Responsibilities:
- Develop and maintain SOPs that comply with GMP, GDP, and regulatory standards.
- Collaborate with SMEs to gather accurate process information.
- Standardize documentation using templates and style guides.
- Support training sessions and create training materials based on SOPs.
- Manage controlled documents using document management systems.
Qualifications:
- Bachelors degree in Technical Writing, Life Sciences, or related field.
- 3-5 years of experience in biopharma/pharma manufacturing documentation.
Skills:
- Strong writing, editing, and proofreading skills.
- Knowledge of GMP, FDA regulations, and biopharma manufacturing processes.
- Proficiency in document management tools (e.g., Veeva).