Description:
The Document Control Assistant is responsible for administering the processes and practices which support documentation compliance. The Specialist will work in a pharmaceutical production facility and in close collaboration with Quality Assurance, Quality Control and Production with a key-focus on documentation accuracy, quality and integrity.
Essential Functions:
- Manage document control processes thru electronic systems and/ or paper base systems. Distribute approved documentation to appropriate personnel, track receipt of documentation and notebooks.
- Maintaining lists and postings required for both electronic and hard copy; maintain specific databases in Document Control Department and training records.
- Perform data entry and management in systems (Document Compliance and Process Compliance) and maintain the print/soft copies for all documents.
- Collaborate with teams to complete, maintain an up-to-date Document Control Systems.
- Store, archive, and retrieve the version documents such as certificate of analysis of materials and products, specifications, methods, protocols, and report files.
- Prepare and distribute PBRs, Packaging Batch Records, SOPs, methods and protocols, and other controlled documents.
- Distribute approved documentation to appropriate personnel, track receipt of documentation and notebooks. Track document approvals and any related activities and ensure on-line documents are updated and accurate.
- Work with other departments to clarify and correct documentation to ensure compliance.
- Organize and maintain the work area and keep up-to-date files
Additional Responsibilities:
- Prepare documentation for third party inspection/audits.
- Assist validation and regulatory department for documentation and for their various requirements.