Responsibilities:
- Provide expert consultancy in equipment, process, facilities, and utilities qualification, GMP Compliance, process validation, Computer System Validation (CSV), and manufacturing operations management.
- Deliver Risk Management and Quality Management services for Pharmaceutical Manufacturing Operations Projects.
- Conduct sFAT and review vendor turnover package documents for Ultra-Diafiltration skid, chromatography columns, and supporting components.
- Manage change controls for continuous improvement projects and coordinate with cross-functional teams to implement changes.
- Author and execute test scripts for engineering changes.
Requirement:
- Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, or a related field.
- Proven experience in pharmaceutical downstream manufacturing experience who have done some CQ.
- Strong understanding of regulatory requirements, including FDA and EMA guidelines.
Interested candidates can forward their CVs in MS Word format to [email protected]
Reg No. R1549345
Triton AI Pte Ltd
License no. 21C0661
