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).
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