Job Description
Identifying, planning, and implementation of validation requirements in a GMP environment, including cleanroom, equipment, instruments, and manufacturing or testing processes. ● Preparation of the URS for the equipment, utilities, and facilities. ● Preparation of room datasheets for the facilities. ● Prepare, execute, and completion of OQ, IQ, and PQ protocols. ● Prepare schedule or plan for the requalification of equipment/facilities as per the Impact and risk assessment. ● Prepare a protocol for the requalification and execute it as per schedule. ● Performing qualification tests. ● Process validation and media fill. ● Preparation and execution of process validation, protocols, and report. ● Risk assessment and Impact assessment. ● Applying a risk-based approach to all validation activities. ● Implementation of system impact assessment and component criticality for equipment, utilities, and facilities. ● Statistical analysis and interpretation of test results.
Requirements
Bachelor’s or Master's degree in Microbiology, Chemical Engineering, Chemistry, Biotechnology. Skill: ● Must be able to work in a fast-paced environment where multitasking is required. ● Upper-intermediate at English. ● Familiar with the principles and foundations of quality assurance, qualification, validation of pharmaceutical processes. ● Familiar with process models. ● Familiar with GMP principle. ● Familiar with statistics, data analysis, and process analysis. ● High responsibility and interested in teamwork. ● Have a high spirit of cooperation and public relations to communicate with other departments. ● Familiar with the production of biological products.
Employment Type
Job Category
Seniority
Details
Employment type
Job Category
Seniority