QA Specialist Trainee - Change Control (Train & Place)

About the role

Roche is recruiting a QA Specialist Trainee under its Train & Place programme in Central Singapore. The role is responsible for maintaining and continuously improving the Change Control systems and processes and for ensuring GMP compliance with the change control process.

Key responsibilities

• Ensure adherence to Change Control management systems and processes, and develop proficiency in the QA Change Control process and its tools, including supporting training for change users
• Evaluate Change Control requests for process, validation, regulatory and product impact, and coordinate their review and approval to meet timelines and the expectations of the global change control board
• Manage site major changes and take part in cross-functional, cross-site change management forums
• Complete required change control actions before lifting lot disposition restrictions, and assist in developing and delivering training materials and qualifications
• Perform Change Records reviews in support of Annual Product Review activities
• Support regulatory inspections and audits, which may include reviewing facility, utility and equipment documentation
• Comply with site safety, health and environmental requirements, observe site security measures and report accidents, near misses and hazards
• Apply the Lean Production System tools to continuous improvement initiatives

Required profile

• Diploma or degree in Engineering or Science preferred
• Fresh graduates or mid-career professionals switching from another industry
• Experience varies depending on site size and scope

Required skills

• Strong knowledge of Change Control principles, practices and standards in the pharmaceutical industry
• Strong knowledge of cGMP regulations relevant to the pharmaceutical industry
• Excellent verbal and written communication skills in English
• Systematic, meticulous and analytical approach to task evaluation and execution