Scan, verify and upload documents into archiving system, including WO (Work Orders), Protocol, Protocol/Report etc.
Review and archive Quality Records such as Qualification package, Preventive Maintenance forms, Training records, etc.
Verify changed document for completeness and accuracy, and ensure change category and appropriate approval are chosen in the change control request system. Clarify any discrepancies and seek closure with cross-functional team.
Coordinate Annual/Ad-hoc External Archival Process, including indexing and packaging documents
Provide administrative support for audit backroom activities and ensure timely response to documentation requests for auditors during external audits
Maintain Site Master Signature Log, ensuring all new employees are added and all terminated employees are removed
Process, update and release changes in Document Control Module of JDE system
Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records.
Other incidental duties (e.g. administrative support including retrieval of documents, records destruction, tracking loan status/retention period, etc.)
Education and Experience
Diploma, 3 years years experience working experience in documentation related function in medical device or pharmaceutical industry
Required Knowledge of Microsoft office applications
Flexibility to work overtime as required
Ability to read, comprehend, and write English; good communication and interpersonal skills, required
Must be able to work independently as well as in a team environment
Experience with PDM (Product Documentation Management) or PLM (Product Lifecycle Management) preferred
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control