Quality Operations Intern

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Job Description

Objective:

In this internship position, the intern will be a member of the Quality Operations (QO) team in providing quality oversight to the manufacturing team to ensure GMP compliance at Takeda Singapore.

Responsibility

• QO Operations

o   Support the manufacturing team with development and writing of process standard operating procedures, master batch records and Forms, ensuring compliance with current good documentation practices and the applicable global procedures and regulatory requirements.

Review executed Manufacturing Batch Records (MBR) / Manufacturing Formulation

Records (MFR)/ Batch Record Report (BRR) of PAS-X

o    Participate with the various subject matter expert to ensure compliance where gaps are identified, ensure that an implementation/ mitigation plan is in place and follow-through to completion.

o   Support the manufacturing team with any quality interpretation, queries and issues.

• Other responsibilities (if assigned)

o   Participate in process improvements/studies with the manufacturing team.

o   Perform timely archival of QO documents.

o   Any other duties as assigned by supervisor

• Leadership

o   Build strong partnership with all other departments to ensure open communications and acceptance

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

Locations

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