Chemist II (Raw Material)

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Job Description

Job Title: Chemist II (Raw Material)
Location: Woodlands, Singapore

About the role:

This position is required perform all tasks associated with the QC raw material lab operations which include chemical analysis, equipment calibration/maintenance, records review, records approval, deviation/ investigation write up/review, equipment qualification, method validation, method transfer and other tasks as assigned.

How you will contribute:

Core Responsibilities:

• Perform analysis of water and cleaning samples as well as incoming raw material samples.
• Ensure tests assigned are performed in a timely manner in compliance to Standard Operating procedures
• Perform equipment calibration and maintenance.
• Perform review/approval of QC records/ log books.
• Initiate and participate in Out Of Specification (OOS), Invalid test and Lab Deviation Investigation Write-Up and assist in timely closure of laboratory invalid results, lab investigation and CAPA with minimum guidance.
• Write/revise SOPs, forms, training qualifications (TQ) and risk assessments (RA).
• Act as a Subject Matter Expert (SME) to provide technical advice to QC Personnel in laboratory related troubleshooting, e.g. lab equipment failure, method
• Perform compendia review
• Provide appropriate training for the QC Raw Material Team.
• Participate in method validation/ transfer or equipment qualification when necessary
• Ensure proper, safe handling and disposal of waste; ensuring a safe working environment.

General Responsibilities:

• Carry out 5S and ensures good housekeeping of Raw Material Lab area.
• Support and participates in Operation Excellence initiatives (such as GEMBA and GMP walk).
• Lead in cross functional investigation.
• Coach and mentor junior Chemist.
• Assist supervisor in reviewing of material specification.
• Participate in projects towards improving safety performance and continuous improvement initiatives.
• Demonstrate strong technical knowledge and associated regulatory expectation.
• QC Chemist may cover for another QC Chemist of similar functions/areas in his/her absence by signing documents on his/her behalf.
• Assist QC Supervisor to support internal and external compliance audits.
• 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.

What you bring to Takeda:

 Education and Experience Requirements

• Bachelor Degree in Chemistry, Biochemistry, Biotechnology or equivalent, preferably with more than 4 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment.

• Demonstrated strong technical experience e.g. in the area of method validation, method transfer, equipment qualification, OOS investigation and associated regulatory expectation.

• Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

Key Skills and Competencies

Project Management Skills

• Organization and planning skills
• Analytical and Logical thinking skills
• Ability to work and collaborate within the team and across departments

Technical Skills

• Has substantial knowledge and understanding in terms of regulatory standards requirements e.g. USP, EP, 21CFR, ICH etc.
• Knowledge in Total Organic Carbon (TOC), Conductivity, Gas Chromatography (GC), FTIR, UV, auto titrator and Karl Fischer (KF).
• Knowledge in Empower and LIMS.
• Knowledge in Microsoft Office.

Problem solving

• Solves problems and implements corrective actions using six sigma tools.
• Be a subject matter expert in given areas of responsibilities and able to solve issues related to his/her area of expertise.
• Knowledge in safety principles, practices, regulations and procedure related to the work.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

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