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, where 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 and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
1) Purpose
- Responsible for the maintenance and continuous improvement of the Change Control systems and processes.
- Ensure GMP compliance with the change control process.
2) Key Responsibilities
Technical and Functional:
- 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 meets 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, to 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.
3) Key Interfaces:
- Manufacturing, Local MSAT, Engineering
- Quality Functions (e.g. QA Ops, QC)
- Global Change Management BPOs and BPMs
- PT Regulatory
4) Qualifications
- Education:
- Diploma/Degree in Engineering or Science discipline is preferred
- Experience (may vary depending on site size/scope):
- Fresh graduates/mid-career professionals who are switching out of other industries
- Knowledge/Skills/Competencies
- Strong knowledge in 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
Who we are
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
Roche is an Equal Opportunity Employer.
