Manufacturing Services Intern

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Job Description

Objective:

To provide a meaningful working experience for interns through on-the-job training with the Manufacturing Services (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:

Intern will be responsible for providing administrative support in all aspect of Documentation as follows: -

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

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• Print controlled copies and replace superseded copies in the manufacturing area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

Other documentation support

• Formatting of Manufacturing and Engineering documents
• Issuance of Ad-hoc labels (e.g. Cleaning Monitoring)
• Support investigation for event and deviation

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

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

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

• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.

Any other duties as assigned by supervisor.

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

Locations

SGP - Singapore - Woodlands

Worker Type

Employee

Worker Sub-Type

Paid Intern (Fixed Term) (Trainee)

Time Type

Full time