- Reporting to the Document Control Supervisor, this role supports the Document Control Supervisor by being responsible for assuring that the Site's documentation management system supports Quality and Operational purposes and is compliant with applicable regulatory requirements
- Document Control Assistant is accountable to process documentation change requests as documentation controller within Documentation Management System.
- Ensures the control of changes through the validated document control system in place following approved document change control policies, process and procedures.
- Administrate processing of all documentation Change Plan/Requests for creation or changing of documents through the current Document Management System following applicable policies, process and procedures as part of documentation lifecycle management
- Support Controlled Issuance of paper records (eg. batch records, logbooks, SOPs) distributed to respective area for execution
- Support of record reconciliation, archival and retention of Quality area documents. Assure all controlled documents are retained according to company Policies and procedures
- Maintain compliance for Site GMP documentation lifecycle management activities including but not limited to document change management, archival/retrieval, controlled document issuance and GMP third party record management to ensure compliance with GMP and data integrity requirements
- Comply to GDP (Good Documentation Practices)
- Any other tasks as and when assigned by the Document Control Supervisor
- Support global documentation team initiatives or other site improvement projects
Requirements:
- min. Diploma in any discpline
- Possess 3-5 years prior working experience in document control functions, preferably in an MNC and GMP environment
- Able to start work immediately or within short notice
Interested candidates please send your updated resume in MS Word Format to:
[Confidential Information]
Subject: Document Controller
EA Personnel: Kate Leau Wei Xuan (R1552331)
Company Registration No.: 99C4599
