Job Description

Job Title: Document Control Specialist

Department: Pharmaceutical and Biotechnology

Type: Contract

Location: Remote

Experience:0-2 years

Job Summary

The Document Control Specialist is responsible for managing, organizing, and maintaining controlled documents in compliance with regulatory standards. This role ensures accuracy, traceability, and proper documentation practices in pharmaceutical operations such as manufacturing, quality assurance, and regulatory affairs

Key Responsibilities

• Maintain and manage controlled documents such as:
  • SOPs (Standard Operating Procedures)
  • Batch Manufacturing Records (BMRs)
  • Batch Packaging Records (BPRs)
  • Validation protocols and reports
• Ensure documents comply with:
  • GMP guidelines
  • Regulatory requirements (e.g., FDA, WHO, EU guidelines)
• Perform document control activities:
  • Document numbering, formatting, version control
  • Issuance, retrieval, archival, and destruction of records
  • Tracking document revisions and approvals
• Coordinate with departments like:
  • Quality Assurance (QA)
  • Production
  • Regulatory Affairs
• Maintain document logs and databases (manual or electronic systems)
• Support audits by:
  • Retrieving documents
  • Ensuring proper documentation practices

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