About the role
AI summarisedEntry-level QA role focused on pharmaceutical change control processes. Responsible for maintaining GMP-compliant change management systems, evaluating change requests, coordinating approvals, and supporting audits and training activities.
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 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
- 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
Requirements
- 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
- 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