Pharma Documentation Specialist

Role & responsibilities

• Prepare, format, revise, and maintain SOPs, work instructions, forms, and controlled documents.
• Collaborate with Manufacturing, QA, QC, and Engineering teams to collect technical information and incorporate feedback.
• Review documents for accuracy, completeness, consistency, and compliance with approved templates and procedures.
• Monitor document revisions, review comments, approvals, and pending actions.
• Support document routing, issuance, version control, retrieval, and archival.
• Ensure compliance with Good Documentation Practices (GDP) and applicable GMP requirements.
• Maintain well-organized documentation to support daily operations, inspections, and audit readiness.

Preferred Candidate

• Experience in pharmaceutical or biopharmaceutical documentation and document management.
• Working knowledge of Manufacturing, QA, QC, and Engineering functions.
• Familiarity with controlled document processes and Good Documentation Practices (GDP).
• Strong technical writing, proofreading, organizational, and communication skills.
• Proficiency in Microsoft Word and Excel.
• Experience with Electronic Document Management Systems (EDMS) is preferred