Our client is a research and development-driven pharmaceutical company.
About the role:
Plan, Perform, and Coordinate Computer System Validation, Equipment Qualification, Temperature Controlled Objects (Freezers, Incubator, etc.)
Clean Utility Validation in accordance with the Company’s internal procedures and industry standards. The qualification includes FAT, SAT, IQ, OQ, PQ of any additional/ modifications of existing manufacturing process equipment, package units (e.g. Ultrafiltration Unit, Chromatography Columns, autoclave, FIT testers), commercial off the shelves (COTS) analytical instruments, freezers
Create, review and approve equipment qualification and analytical instruments lifecycle documentations, e.g. FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications
Coordinate the commissioning and qualification activities (including the creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents)
Lead daily validation meetings with cross-functional in resolving validation issues
Experience in equipment qualification including analytical instrumentation and manufacturing equipment
Experience in ASTM2500 of process equipment commissioning and qualification (Ultrafiltration units and chromatography column is preferred)
Be Knowledgeable about Data Integrity topics
Do regular progress report of project deliverables for Supervisor/ Project Lead
Carry out any other duties as assigned by the Supervisor/ Designated Person
Minimum of 5 years of related Validation experience in the life science industry (i.e. medical device/IVD, pharmaceutical, biotech
Experience to creates, Reviews, Approve computer system validation lifecycle documentations, e.g. FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
Experience in coordinate cross functional (including local and global teams) for the creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents
Experience in managing the qualification protocol execution process (cross functional), deviations management, and status reporting
Experience in leading daily validation meetings with cross functional in resolving validation issues.
Proficient in use of MS Office
Proficient in technical write up of validation lifecycle documentation (e.g. validation project plan, validation protocols, validation reports, validation discrepancies)
Proficient in application of risk assessment such as FMEA
Experience in computer system validation in qualifying process control systems.
Knowledge in recombinant processes under GMP environment
Bachelor's Degree, Post Graduate Diploma, Professional Degree
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