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).