QA Change Control Trainee: Learn GMP, Propel Impact

Roche; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Roche Singapore is seeking a Change Control professional to maintain and improve the Change Control systems within a GMP framework. The role focuses on evaluating requests, coordinating approvals, and ensuring timely changes across the site while supporting training and audits.

You will collaborate with Manufacturing, QA Ops, and Regulatory teams to deliver compliant, well-documented change activities and contribute to a culture of safety, quality, and continuous improvement.

Qualifications

• Education: Diploma/Degree in Engineering or Science
• Fresh graduates/mid-career professionals who are switching out of other industries
• Strong knowledge in Change Control principles, practices and standards for the pharmaceutical industry
• Strong knowledge of cGMP regulations relevant to the pharmaceutical industry
• Systematic, meticulous and analytical approach to evaluation and execution of tasks.
• Demonstrate excellent verbal and written communication skills in English

Responsibilities

• Ensure adherence to the Change Control management systems and processes
• Develop competency and proficiency in the QA Change Control process and the associated tools, supporting the delivery of training for change users as needed
• Evaluate Change Control requests for process, validation, regulatory and product impact
• Coordinate the review and approval process of change requests to ensure timely execution of changes
• Ensure all site major changes are managed appropriately to meet the expectation of the global change control board and meets site project timelines
• Participate in cross functional and cross site change management forums
• Collaborate with departments to ensure change control activities are executed efficiently and effectively, to provide supporting assistance to stakeholders in the process
• Ensure completion of required change control actions prior to lifting lot disposition restrictions
• Assist in the development and delivery of training materials and qualifications for Change Control processes and Change Management applications
• Perform Change Records review in support of Annual Product Review activities
• Ensure maintenance and continuous improvement of change control and processes
• Support regulatory inspections and provide audit support, which may include facility, utility, equipment documentation review
• Comply with all RSTO’s Safety, Health & Environment 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.

Skills

Change Control

cGMP

Regulatory compliance

Quality assurance

Training delivery

Education

Diploma/Degree in Engineering or Science

Fresh graduates/mid-career switchers

Tools

Change Control software

Documentation systems

Job description

Roche Singapore is seeking a Change Control professional to maintain and improve the Change Control systems within a GMP framework. The role focuses on evaluating requests, coordinating approvals, and ensuring timely changes across the site while supporting training and audits.

You will collaborate with Manufacturing, QA Ops, and Regulatory teams to deliver compliant, well-documented change activities and contribute to a culture of safety, quality, and continuous improvement.