QA Specialist Trainee - Train & Place program

F. Hoffmann-La Roche AG; Singapore; On-site; SGD 50,000 - 75,000; Full time

Job summary

F. Hoffmann-La Roche AG in Singapore is seeking a qualified individual to oversee Change Control systems and processes. The role involves ensuring compliance with GMP regulations and managing the review of change requests effectively.

The ideal candidate will possess a diploma or degree in Engineering or Science and have strong knowledge of Change Control principles. Fresh graduates or professionals transitioning into this role from other industries are encouraged to apply. This position emphasizes safety and effective collaboration across departments.

Qualifications

• Strong knowledge of Change Control principles and practices in the pharmaceutical industry.
• Fresh graduates or mid-career professionals transitioning from other industries are welcomed.

Responsibilities

• Ensure adherence to Change Control management systems and processes.
• Evaluate Change Control requests for their impact on processes and products.
• Coordinate the approval process for change requests.

Skills

Change Control principles

cGMP regulations

Analytical approach

Communication skills in English

Education

Diploma/Degree in Engineering or Science

Job description

Purpose

Responsible for the maintenance and continuous improvement of the Change Control systems and processes. Ensure GMP compliance with the change control process.

Key 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 meet 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, and 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

Safety, Health & Environment

Comply with all RSTO’s 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’s 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.

Key Interfaces

• Manufacturing
• Local MSAT
• Engineering Quality Functions (e.g., QA Ops, QC)
• Global Change Management BPOs and BPMs
• PT Regulatory

Qualifications

Education

Diploma/Degree in Engineering or Science discipline is preferred.

Experience

Fresh graduates/mid‑career professionals who are switching out of other industries.

Knowledge / Skills / Competencies

• Strong knowledge of 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

Equal Opportunity Employer

Roche is an Equal Opportunity Employer.