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.