Maintain and manage the document control system, ensuring all documents are up-to-date, accurately categorized, and accessible.
Coordinate the creation, revision, approval, and archiving of controlled documents such as Standard Operating Procedures (SOPs), Work Instructions, and Specifications.
Ensure all quality documents comply with applicable regulatory requirements (e.g., FDA, EMA, ICH guidelines).
Support audits and inspections by providing relevant documentation and ensuring document readiness.
Train employees on document management processes and ensure adherence to documentation protocols.
Provide support to team members in document preparation and formatting.
Maintain electronic document management systems (EDMS) or similar platforms for document storage and retrieval.
Generate periodic reports on document status, revision cycles, and compliance metrics.
Identify opportunities for improving documentation workflows and implement solutions.
Participate in quality initiatives to enhance overall compliance and efficiency.
Work closely with Quality Assurance, Regulatory Affairs, Manufacturing, and other departments to ensure document accuracy and relevance.
Facilitate cross-functional reviews and approvals for critical documentation.
Qualifications:
Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field.
Minimum 2-4 years of experience in document management, quality assurance, or a related role within the biopharma industry.
Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Experience with electronic document management systems (e.g., Veeva, MasterControl, or similar) is a plus.
Strong organizational skills and attention to detail.
Excellent written and verbal communication abilities.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Ability to manage multiple priorities and meet deadlines.
Certification in Quality Assurance or Document Control (e.g., ISO 9001, ASQ) is advantageous.
