Assist in preparing, formatting and reviewing controlled documents such as SOPs, Work Instructions, Forms, Specifications and Policies.
Maintain document numbering, version control and revision history. Support the issuance, distribution, retrieval and archival of controlled documents.
Ensure obsolete documents are removed from points of use and archived according to company procedures. Update and maintain the Document Master List. Scan, organise and maintain both electronic and hardcopy document records. Assist departments in document submission and approval workflows.
Support internal and external audits by preparing requested documentation. Ensure document confidentiality and security at all times.
Assist in maintaining training records related to controlled documents. Perform other administrative and documentation duties assigned by the supervisor.
Learning Opportunities
During the internship, the intern will gain exposure to:
Good Documentation Practice (GDP).
Good Manufacturing Practice (GMP) documentation requirements.
ISO 9001 / ISO 13485 document control systems (where applicable).
Electronic Document Management Systems (EDMS).
Quality Management System (QMS) documentation. Internal audit documentation processes.
Cross-functional collaboration within pharmaceutical manufacturing.