QA Specialist Trainee - Train & Place program

About the role

This position sits within Roche’s quality assurance function and focuses on maintaining and improving the change control system and related workflows. The role is centered on ensuring GMP-aligned handling of changes across site operations, while supporting training, documentation, reviews, and cross-functional coordination.

Roche promotes an inclusive environment where individuality, open communication, and mutual respect are encouraged. The organisation’s broader mission is to advance healthcare by preventing, stopping, and curing diseases and improving access to treatment for current and future generations.

Key responsibilities

• Maintain and continuously strengthen the change control framework, systems, and processes.
• Work in line with change control procedures and site governance requirements.
• Build working knowledge of QA change control tools and processes, and help deliver user training where required.
• Assess change requests for impact on processes, validation, regulations, and products.
• Coordinate review and approval activities so changes are completed within required timelines.
• Make sure major site changes are handled in a way that satisfies global change control expectations and project schedules.
• Take part in cross-functional and cross-site change management discussions and forums.
• Partner with internal departments to ensure change control tasks are carried out smoothly and efficiently.
• Confirm that all required change-related actions are completed before lot disposition restrictions are removed.
• Support the creation and delivery of training content and qualifications for change control processes and related applications.
• Review change records to support Annual Product Review activities.
• Contribute to ongoing improvement of change control processes and documentation.
• Support regulatory inspections and audit readiness, including review of facility, utility, and equipment documentation as needed.
• Follow all Safety, Health & Environment requirements and promptly report accidents, near misses, and hazards.
• Observe site security procedures at all times and immediately report suspicious persons, objects, or damaged security controls.
• Adopt a Lean Production System mindset and apply continuous improvement tools and behaviours in day-to-day work.

Work interfaces

This role works closely with Manufacturing, Local MSAT, Engineering, Quality teams such as QA Ops and QC, Global Change Management BPOs and BPMs, and PT Regulatory.

Qualifications and experience

A diploma or degree in Engineering or a Science discipline is preferred. The role is open to fresh graduates as well as mid-career professionals transitioning from other industries.

Required knowledge and skills

The ideal candidate should have a strong understanding of change control principles, pharmaceutical industry standards, and cGMP requirements. The role also calls for a systematic, careful, and analytical way of working, together with strong spoken and written English communication skills.

About Roche

Roche is a global healthcare company committed to advancing science and improving patient outcomes. With a large international workforce, the company works across medicines and diagnostics to help more people access better healthcare.

Equal opportunity

Roche is an equal opportunity employer.