Job Responsibilities
1. Manufacturing Operations & Process Execution
- Execute manufacturing operations in compliance with SOP and MBR requirements, ensuring activities are completed as scheduled and all records are completed accurately and timely.
- Perform drug conjugation reactions, purification, weighing, sampling, and sample management activities.
- Operate and support equipment related to conjugation and purification processes to ensure safe and efficient manufacturing operations.
2. Equipment Qualification & Facility Support
- Participate in FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), and IOPQ (Installation, Operational, and Performance Qualification) activities.
- Support workshop and facility maintenance to ensure production equipment and facilities operate as intended and meet operational requirements.
3. Quality Compliance & Documentation