Job Description

Job Responsibilities:

• Collaborate with stakeholders and SMEs to draft, review, and approve technical documents.
• Author and edit SOPs, validation protocols/reports, test methods, work instructions, and change control records.
• Ensure compliance with FDA, EMA, ICH, and cGMP regulatory guidelines, as well as company policies and quality standards.
• Translate complex scientific information into clear, concise, and user-friendly documentation.
• Manage the full document lifecycle, including drafting, reviews, approvals, revisions, and archival in EDMS.
• Facilitate document review meetings and incorporate feedback to ensure accuracy and consistency.
• Maintain a unified style, terminology, and format across all documentation.
• Review documents for scientific accuracy, clarity, and adherence to GMP standards.

Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology, or related field.
• Proven experience in scientific and/or technical writing.
• Excellent written and verbal communication skills.

Preferred Experience:

• 1+ years in Quality Control (QC).
• 3–5 years in pharmaceutical/biopharmaceutical industry.
• Strong knowledge of cGMP regulations and Quality standards.
• Experience writing validation and qualification reports.
• Strong analytical and problem-solving skills.

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