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