About the role
AI summarisedJoin Roche as a QA Specialist Trainee in this Train & Place program. You will be responsible for maintaining and continuously improving Change Control systems and processes while ensuring strict GMP compliance within a culture dedicated to advancing healthcare globally.
BiopharmaOnsite
Key Responsibilities
- 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 of change requests to ensure timely execution.
- Manage site major changes according to global expectations and project timelines.
- Collaborate cross-functionally and across sites to execute change control activities efficiently.
- Ensure completion of required change control actions before lifting lot disposition restrictions.
- Assist in developing and delivering training materials for Change Control processes and applications.
- Perform Change Records review to support Annual Product Review activities.
- Support regulatory inspections and provide audit assistance, including documentation review.
Requirements
- Strong knowledge of Change Control principles, practices, and standards for the pharmaceutical industry.
- Thorough understanding of cGMP regulations relevant to the pharmaceutical industry.
- Systematic, meticulous, and analytical approach to task evaluation and execution.
- Excellent verbal and written communication skills in English.
- Diploma/Degree in Engineering or Science discipline is preferred.
- Fresh graduates or mid-career professionals transitioning from other industries are considered.