OUR CULTURE
At Roche, you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections. You are valued, accepted, and respected for who you are, allowing you to thrive both personally and professionally.
This is how we aim to prevent, stop, and cure diseases—ensuring everyone has access to healthcare today and for generations to come.
Join Roche, where every voice matters.
POSITION DETAILS
Role: QA Change Control Specialist
Company: Roche
Location: Singapore
Department: Quality Assurance
Reports to: Quality Assurance Management
Education: Diploma or Degree in Engineering or Science discipline preferred
Experience: Fresh graduates and mid-career professionals welcome
Employment Type: Full-time
PURPOSE OF THE ROLE
The QA Change Control Specialist is responsible for the maintenance and continuous improvement of the Change Control systems and processes. This role ensures GMP compliance with the change control process across the site.
Change control is a critical quality system in pharmaceutical manufacturing. Every change to processes, equipment, facilities, or documentation must be evaluated, approved, and managed to ensure product quality and patient safety remain uncompromised.
You will be the person who ensures this happens correctly and consistently.
WHY THIS ROLE MATTERS
In pharmaceutical manufacturing, change is constant. Processes improve. Equipment gets upgraded. Facilities are modified. Documentation is updated.
But every change carries risk. A seemingly minor modification could impact product quality, patient safety, or regulatory compliance.
The Change Control system manages this risk. It ensures every change is evaluated, approved, and implemented in a controlled manner.
As QA Change Control Specialist, you own this system. You evaluate change requests. You coordinate reviews. You ensure all required actions are completed before changes are implemented. You keep the site compliant and products safe.
KEY RESPONSIBILITIES
Change Control Management
Ensure adherence to the Change Control management systems and processes. Evaluate Change Control requests for process, validation, regulatory, and product impact. Coordinate the review and approval process to ensure timely execution of changes.
Compliance and Quality
Ensure all site major changes are managed appropriately to meet global change control board expectations and site project timelines. Ensure completion of required change control actions prior to lifting lot disposition restrictions. Perform Change Records review in support of Annual Product Review activities.
Training and Development
Develop competency and proficiency in the QA Change Control process and associated tools. Support delivery of training for change users as needed. Assist in the development and delivery of training materials and qualifications for Change Control processes and applications.
Collaboration and Communication
Participate in cross-functional and cross-site change management forums. Collaborate with departments to ensure change control activities are executed efficiently and effectively. Provide supporting assistance to stakeholders throughout the process.
Continuous Improvement
Ensure maintenance and continuous improvement of change control systems and processes. Apply Lean Production System (LPS) tools and principles. Demonstrate a continuous improvement mindset in all activities.
Audit and Inspection Support
Support regulatory inspections. Provide audit support including facility, utility, and equipment documentation review. Ensure change control records are inspection-ready at all times.
Safety and Environment
Comply with all Safety, Health and Environmental requirements. Never put yourself or others at risk. Report any workplace accidents, near misses, and hazards as soon as practicable. Observe all site security measures and report concerns immediately.
KEY INTERFACES
You will work closely with:
- Manufacturing
- Local MSAT (Manufacturing Science and Technology)
- Engineering
- Quality Operations
- Quality Control
- Global Change Management BPOs and BPMs
- PT Regulatory
QUALIFICATIONS
Education
Diploma or Degree in Engineering or Science discipline is preferred.
Experience
Fresh graduates are welcome to apply. Mid-career professionals switching from other industries are also encouraged.
Knowledge and Skills
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. Excellent verbal and written communication skills in English.
WHAT YOU WILL LEARN AND DEVELOP
Technical Knowledge
Deep understanding of Change Control principles and practices. cGMP regulations and their application. Pharmaceutical manufacturing processes. Quality systems integration. Regulatory expectations for change management.
Professional Skills
Cross-functional collaboration. Stakeholder management. Analytical evaluation and risk assessment. Training and development. Continuous improvement methodologies. Audit and inspection readiness.
Personal Growth
Confidence in quality decision-making. Ability to influence without authority. Systematic problem-solving. Communication across diverse teams. Ownership and accountability.
A TYPICAL WEEK MIGHT INCLUDE
Monday
Review new Change Control requests submitted over the weekend. Evaluate each for process, validation, and regulatory impact. Assign for further review as needed.
Tuesday
Coordinate a cross-functional meeting to discuss a complex change involving Manufacturing, Engineering, and MSAT. Ensure all perspectives are considered before approval.
Wednesday
Provide training to a new change user on the Change Control process and tools. Answer questions and guide them through their first submission.
Thursday
Support an internal audit preparation by reviewing Change Control records for completeness and compliance. Address any gaps identified.
Friday
Participate in a continuous improvement workshop applying LPS tools to streamline the change approval process. Document findings and propose improvements.
WHY ROCHE
Global Leader
Roche is one of the world's leading research-focused healthcare groups, with more than 100,000 employees across 100 countries. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products.
Commitment to Quality
We maintain the highest standards of cGMP and quality. You will learn what excellence looks like in a world-class pharmaceutical environment.
Inclusive Culture
We believe inclusion is key to understanding people's varied healthcare needs. We embrace individuality and value every voice. You can show up as yourself.
Continuous Improvement
We empower each other to explore new possibilities, foster creativity, and keep our ambitions high. The Lean Production System is part of how we work.
Singapore Presence
Roche Singapore is a key part of our global manufacturing network. You will be working at a world-class facility with state-of-the-art operations.
Career Foundation
This role offers the opportunity to build deep expertise in a critical quality system. Whether you are a fresh graduate or switching careers, you will develop skills that are essential across the pharmaceutical industry.
WHAT WE OFFER
Opportunity to work with a global healthcare leader
Comprehensive training in Change Control and quality systems
Supportive and inclusive work environment
Exposure to cross-functional and cross-site collaboration
Professional development and career growth
Purpose-driven work that impacts patient health
APPLICATION PROCESS
Submit your application through the Roche careers portal.
The hiring team reviews all submissions.
Qualified candidates are contacted for an initial conversation.
Interviews are conducted with Quality Assurance leadership.
Decisions and offers are communicated in a timely manner.
TO APPLY
Please submit your resume highlighting your education and any relevant experience. Include a brief note on why you are interested in Quality Assurance and Change Control. Tell us what interests you about Roche.
Apply for the QA Change Control Specialist position at Roche Singapore.
Let's build a healthier future, together.
Roche is an Equal Opportunity Employer. We foster diversity, equity, and inclusion, representing the communities we serve. If you need accommodations during the application process, please let us know.
