Manufacturing Excellence Intern

4 weeks ago


Singapore Takeda Pharmaceutical Full time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.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• Print controlled copies and replace superseded copies in the manufacturing area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



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