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Job Description

Company Profile:

Takeda's Singapore biologics manufacturing facility focuses on manufacturing potentially life-saving medicines for patients suffering from rare blood disorders such as Hemophilia A and B. As part of the company’s Biologics Operating Unit network, the site is Takeda’s only biologics drug substance manufacturing facility in Asia.  The facility has two buildings, including manufacturing suites and laboratories, as well as Takeda’s first positive energy building certified by Singapore’s Building and Construction Authority’s Green Mark scheme in 2022.

Job Title: Senior QC Analyst II (Integrated Testing & Support)

Reporting To: QC Supervisor (Microbiology & Lab Service)
Location: Woodlands, Singapore

About the role:

• This position is required to perform routine chemistry testing, microbiological testing using validated test methods and qualified instruments, and carry out QC activities to support operation such as sample management and lab maintenance etc.

How you will contribute

Routine Testing

• Perform chemical analysis for water and cleaning samples using approved test method SOPs and qualified instruments.

• Perform microbiological testing, namely bioburden test, endotoxin test, Growth Promotion Testing (GPT), Biological Indicator (BI), microbial identification (ID), environmental monitoring (EM), and plate reading.

• Microbiological sample types include critical utilities, in-process / Bulk Drug Substances (BDS), raw materials, investigational and non-routine samples.

• Perform sterilization cycle using qualified autoclave, perform depyrogenation using qualified cycle.

• Perform aliquoting on Process and Non-Protein samples on daily basis

Sample Management

• Perform receiving of sample and distribution of sample

• Prepare and packing of sample that required external shipment

• Manage the backup sample in QC laboratory

Inventory Management

• Manage the inventory of the consumable used for testing.

• Raise Purchase order when required.

Lab Maintenance (Instrument)

• Perform preventive maintenance for laboratory equipment, such as Temperature Controlled Object (TCO), Biosafety Cabinet (BSC), etc.

• Responsible for ownership of sophisticated lab equipment and conduct equipment training to respective lab personnel.

• Arrange equipment calibration with external vendor.

• Manage and maintain service contract with vendor when required.

• Perform peer review on equipment logbook.

Lab Maintenance (System)

• Initiate deviation or laboratory investigation via Trackwise system when required.

• Involve in audit preparation when tasked.

• Participate, support investigation and/or own an investigation when required.

• Participate and support Continuous Improvement (CI) initiative when required.

• Revise Standard Operating Procedures (SOP) and EHS Risk Assessment.

• Perform data compilation and trending.

• Have a good understanding on 5S methodology; report/highlight issues or unsafe act.

• Ensure and maintain good housekeeping; ensure sufficient inventory to prevent any delays in testing.

General Responsibilities

• 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

• Diploma in Chemistry, Microbiology, Biological Sciences, Life Sciences, Biotechnology or equivalent with 2-3 years of related laboratory experience.

• Degree in Chemistry, Microbiology, Biological Sciences, Life Sciences, Biotechnology or equivalent with 2 years of industrial experience.

• Preferably experience in performing QC testing.

• Able to work on rotating shift

• Will work holidays and overtime as required

Key Skills and Competencies

Technical Skills

• Vigilant in highlight / report issues.

• Able propose ideas / suggestion within QC.

• Knowledge in cGMP quality system and industry guidelines e.g. GEMS, Change Control, release, documentation etc.

• Organized and detailed to drive completion of assigned tasks.

• Knowledge with Microsoft Office applications.

• Knowledge of Safety principles, practices, regulations and procedure related to the work.

Mindset & Behavior

• Committed to the role assigned.

• Positive mindset and motivated.

• Able to understand constraints at times and be flexible.

• Good interpersonal, Verbal and Written Communication Skills required.

• Ability to work and collaborate within the team.

• Good in emotional handling.

• Good time management skills.

• Good communication and problem-solving skills.

• Strong work ethics and positive attitude

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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