- Contribute to the maintenance and continuous improvement of the Record Management systems and processes.
- Perform the creation and revision of site and/or corporate level quality documents that support GMP operations to ensure compliance with cGMP guidelines and additional Roche quality standards
- Ensure GMP compliance with the record management process.
- Perform activities associated with the receipt, retrieval, maintenance and tracking of records utilizing the record management system
- Perform routine administrative activities such as filling, scanning and archiving.
- Create and edit controlled documents consistent with current formats using the Electronic Document Management System (EDMS).
- Provide assistance in the review of documents for accuracy and completeness as requested.
- Perform issuance and review of shop packets and logbooks.
- Perform reconciliation of control-printed documents.
- Improve and maintain group metrics to improve communication of customer needs.
- Perform administrative duties including inventory control of office supplies and equipment.
- Trainer on shop packet issuance, logbook issuance and EDMS Document Controller functions.
- Liaise with external Vendor on the maintenance of compactors and off site storage of records
- Support regulatory inspections by providing document administrative and record retrieval tasks
- Comply with all RSTO's Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable
- Observe all RSTO's site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.
- Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviours through the use and application of LPS tools for continuous improvement initiatives.
- Manufacturing, Local MSAT, Engineering, Material Management
- Quality Functions QA Ops, QC)
- Education: At least an equivalent of "O" levels
- Experience (may vary depending on site size/scope): 2 or more years' work experience
- Knowledge/Skills/Competencies Basic knowledge in of record management principles, practices and standards for the pharmaceutical industrySystematic, meticulous and analytical approach to evaluation and execution of tasks.Demonstrate good verbal and written communication skills in EnglishDemonstrate good ability in usage of Microsoft applicationsGood organization and interpersonal skills
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Quality Assurance Coordinator - Singapur, Singapore - Roche
Description
The Position
1) General
Department: Quality Function: Quality Systems and Validation Reports to: Head of Change Control and Record Management Location: Singapore
2) Purpose
3) Key Responsibilities
Technical and Functional:
Safety, Health & Environment:
Lean Production System:
4) Key Interfaces:
5) Qualifications
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