Quality Specialist Trainee (Attach & Train Program)

About the role

Roche is recruiting a Quality Specialist Trainee for its Attach & Train program in Singapore. The role provides QA oversight for RSTO so that investigational medicinal products (IMPs) and commercial medicinal products are manufactured in line with Roche's Pharmaceutical Quality System (PQS) and local site requirements. It also covers escalation of quality issues, routine Make, Assess and Release operations, and participation in departmental and cross-functional initiatives.

Key responsibilities

• Review batch records, batch reports, logbooks, cGMP documents and audit trails to ensure product quality, compliance and on-time batch disposition.
• Provide QA oversight for GMP area, utilities and equipment release, and approve discrepancy justifications for resuming GMP processing.
• Perform periodic floor walks and support or carry out routine Make, Assess and Release operations.
• Escalate quality issues according to the criteria set out in governing documents.
• Take part in designing and implementing department and cross-functional initiatives, and accept additional responsibilities as required by Quality Management.
• Notify senior management of potential quality, regulatory and compliance issues.
• Follow RSTO's safety, health and environmental requirements, site security measures and the Lean Production System, and report accidents, near misses and hazards promptly.

Required profile

• Degree in Life Sciences or Engineering, or equivalent.
• 1-3 years of related experience for degree holders, or equivalent combination of education and experience.
• Experience in a biotech or pharmaceutical environment is a plus.
• Good knowledge of cGMP and GDP relevant to the pharmaceutical industry.
• Ability to prioritise, plan and manage deliverables, with good problem-solving and communication skills.
• Flexible in work hours, including shift work.