- 2 VENTURE DRIVE West Region (Singapore) Singapore
工作地点
职位描述
岗位职责
My client is a big Pharmaceutical Company in Singapore.
What you will do:
· Process Support:Lead the preparation, execution, process monitoring, and post-campaignactivities for cell culture or purification stages of the customer’smanufacturing processes at Singapore production facility. Becomeproficient with all processes in the facility and develop the ability tosupport/lead activities across multiple processes.
· Monitor processeson a regular basis to further understand process behavior and prospectivelyidentify process issues. Develop the ability to generalize issues acrossprocesses. Lead investigations into process trends, issues, or deviationsinvolving multiple departments and customers. Write change requests and driveto implementation.
· Review purificationprocess manufacturing batch records and provide technical input to MFGtechnical document writing specialists. Identify training needs and providetraining materials for MFG operators on cell culture or purification processbatch records.
· Work with MFG toupdate process batch records to enable robust manufacturing operations. SupportGMP and commercial runs, perform technical investigations, and help authortechnical reports to support close-out of deviations, trouble-shoot processexcursions/issues for purification processes.
· Support Preparationof Annual Product Review (APR) and Continued Process Verification (CPV) summaryreports, perform work-stages to support customer BLA filing.
· Maintain processdatabases and monitor batch-to-batch consistency of operations. Supportinspections and audits by customers and regulatory authorities. Providetechnical mentorship and share process knowledge with MSAT team members andother departments. Uphold data integrity principles in accordance with policies. Proactively evaluate, identify, and improve the data integrityprocess. Any other duties as assigned by your Supervisor/Manager.
What we are looking for:
Kris Lam (R1983356)
Director
Recruitmatic Pte. Ltd. (22S1186)
2 Venture Drive #14-02
Vision Exchange S608526
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