Job Information
Takeda Pharmaceuticals Manufacturing Excellence Intern (Jul to Dec 2024) in Singapore, Singapore
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Job Description
We are looking for students who are currently enrolled at a local educational institution and the internship is recognized as part of the school's official curriculum. Successful applicants must commit to a 20/24 weeks internship during the period from Jul - Dec 2024
Objective:
To provide a meaningful working experience for interns through on-the-job training with the Manufacturing Excellence (Documentation) team. The takeaway at the end of internship would be to understand the requirements of Data Integrity in the industry, and expectations of a System Administrator. The intern will also be able to participate in tech transfer activities, regulatory/safety audits and understand the end to end documentation support required to manufacture batches.
General Responsibilities
a. Master Batch Record (MBR)/Manufacturing Formulation Record (MFR) (Process/ Non-process):
• Prepare and issuance of MBR/ MFR packages (include MBR/MFR, and/ or labels)
• Attain operating knowledge in internal in-house system such as PRIMR (for Process Monitoring), LIMS (Sample Management) and JDE (Inventory).
• Perform data interface with PRIMR but not limited to entry, verification, etc.
• Perform JDE transaction
• Attain knowledge in troubleshooting and rectification of JDE errors
• Perform Inventory Adjustment (Scrap/discard)
• Archive completed MBR/MFR
• Perform updating of electronic tracking log
b. Controlled Copy/ Logbook Management
• Check/ verify number of the controlled copies that are effective daily
• Print controlled copies and replace superseded copies in the manufacturing area
• Remove obsolete controlled copies from manufacturing area
• Issue and archive logbook timely
c. Other documentation support
• Formatting of Manufacturing and Engineering documents
• Issuance of Ad-hoc labels (e.g. Cleaning Monitoring)
• Support for printing of LIMS labels and forms for water sampling
• Support investigation for event and deviation
d. Internal/ External Document Archival
• Facilitate loan out/ return of internal archived documents
Arrange for documents to be archived externally, and arrange for retrieval
• Perform 5S inspection
e. Administrative support to Manufacturing Standalone equipment (e.g. Casy Cell Counter, BioProfile pHOx, AKTA Explorer, Filter Integrity Tester, Bag Integrity Tester)
• Administer user access for Manufacturing Standalone equipment
• Perform Annual User review
• Routine time synchronization of system
• Routine backup and archival of data
• Execution of protocol/ test script requiring administrative access
f. Others
• Compile and print JDE Error Report
• Perform troubleshooting and resolve documentation related issue
• Support investigation for non-conformance in Documentation area.
• Actively support continuous improvement initiatives
• Actively support implementation of changes to Documentation
• Act as a SME (Subject Matter Expert) for improvement projects
Requirements:
• Team player, self-driven and able to work under pressure and good time management
• Able to take initiative with problem solving skills
• Excellent team player with hands-on attitude
• Able to adhere to EHS/GMP requirement
• Able to support production demands with adjusted work schedule
• Ability to wear appropriate PPE/Cleanroom gowning as per SOP
• Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.
Locations
SGP - Singapore - Woodlands
Worker Type
Employee
Worker Sub-Type
Paid Intern (Fixed Term) (Trainee)
Time Type
Full time
Takeda Pharmaceuticals
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