Support activities required in change control and archiving of documents/records to ensure quality standards are met and to support the daily DCC (Document Control Center) operation and ad-hoc external audit activities.

　　Key Responsibilities:

　　• 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:

　　Other: in Diploma, 3 years years experience working experience in documentation related function in medical device or pharmaceutical industry Required

　　Additional Skills:

　　• 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