Job 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

• 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.

3) Key Responsibilities

Technical and Functional:

• 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

Safety, Health & Environment:

• Comply with all RSTO\xe2\x80\x99s 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\xe2\x80\x99s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:

• 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.

4) Key Interfaces:

• Manufacturing, Local MSAT, Engineering, Material Management
• Quality Functions (e.g. QA Ops, QC)

5) Qualifications

• Education:

• At least an equivalent of \xe2\x80\x9cO\xe2\x80\x9d levels

• Experience (may vary depending on site size/scope):

• 2 or more years\xe2\x80\x99 work experience

• Knowledge/Skills/Competencies

• Basic knowledge in of record management principles, practices and standards for the pharmaceutical industry
• Systematic, meticulous and analytical approach to evaluation and execution of tasks.
• Demonstrate good verbal and written communication skills in English
• Demonstrate good ability in usage of Microsoft applications
• Good organization and interpersonal skills

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.

Roche