Job Description
The Document Controller will play a crucial role in our organization by implementing and working with an Electronic Document Management System.
This system will be used for the issuance and control of GMP documents for all production and related activities, such as sampling, testing, and qualification.
Main Responsibilities:
* Implementation and management of the Electronic Document Management System.
* Issuance and control of documentation for production, including batch records and logbooks.
* Issuance and retrieval of site standard operating procedures.
* Issuance of qualification documents to engineering and validation departments.
* Issuance and control of QC/ARD specifications, methods, protocols, and artwork specifications.
* Archival and storage of all documentation, including maintenance of the document storage area.
* Preparation of standard operating procedures, reports, and forms as required.
* Leadership in investigations related to document control.
* Support for quality management, QMS, and training departments.
* Process audits for GMP compliance.
* Support during regulatory/customer/corporate audits as needed.
Requirements:
* Minimum Level 5 qualification.
* Experience in implementing and working with an electronic document management system.
* At least 3 years of experience in document control in a pharmaceutical GMP environment.