Manage document control processes thru electronic systems and/ or paper base systems.
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.
Track document approvals and any related activities and ensure on-line documents are updated and accurate.
Distribute approved documentation to appropriate personnel, track receipt of documentation and notebooks.
Work with other departments to clarify and correct documentation to ensure compliance.
Organize and maintain the work area and keep up-to-date files
Maintain high-level of confidentiality, in regards to Company and employee information.
Issue, receive, archive and track logbooks, batch records, etc.
Prepare documentation for third party inspection/audits.
Assist validation and regulatory department for documentation and for their various requirements.
High School or GED - Required
Amneal Pharmaceuticals, Inc.