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Documentation Specialist III (FTC)

Singapore, Singapore
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On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:

  • Small Molecules
  • Biologics
  • Plasma
  • Cell and Gene

As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.

Job ID R0127913 Date posted 07/10/2024 Location Singapore, Singapore

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’sPrivacy Noticeand 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

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: Documentation Specialist III
Location: Woodlands, Singapore

About the role:

With general supervision, the individual will:

  • Provide full documentation supports to Manufacturing.

  • Maintain the administrative system for Manufacturing Batch Records, SOPs, Forms, Logbooks, etc

  • Maintain the documentation and archiving (onsite/offsite) system for technical documents and turnover packages.

  • Manage all quality relevant documentation, organize and improve the respective systems for issuance, workflow and archiving in cooperation with Quality.

  • Provide documentation support for manufacturing processes in according to EHS guidelines and in a cGMP compliant manner.

  • Provide administrative support to Manufacturing Standalone equipment.

How you will contribute

70%: The individual will carry out cGMP documentation operations utilizing Standard Operating Procedures (SOP), Electronic Batch Records (EBM), JD Edwards (JDE), LIMS, Batch Records and Forms.

Primary responsibilities include:

MBR/MFR (Process/ Non-process):

  • Prepare and issuance of MBR/ MFR packages (include MBR/MFR, LIMS, JDE, XFP and/ or custom labels)

  • Prepare and reconciliation of ECC forms

  • Attain in depth operating knowledge in PRIMR, LIMS, JDE and EBM transaction, etc

  • Perform data interface with PRIMR but not limited to entry, verification, data editing, etc

  • Perform JDE transaction but not limited to materials consumption, verification, work order completion (including WO08/11), KU adjustment, etc

  • Attain in depth knowledge in trouble shooting and rectification of JDE/ XPF errors

  • Perform Inventory Adjustment (Scrap/discard)

  • Perform materials transactions of non-work orders (IE) process

  • Archive completed MBR/MFR

  • Review MBR/MFR issuance and movement log

  • Perform updating of electronic tracking log

  • Collaborate closely with other departments to resolve issues related to daily operations

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 from manufacturing area

  • Perform issuing and archival of logbook timely

Other Documentation Support

  • Formatting of Manufacturing and Engineering documents

  • Issuance of Ad-hoc labels (Cleaning Monitoring/ In-Ops/ DHT, etc)

  • Support for printing of LIMS labels and forms for water sampling

  • Audit Support

  • Lead and Support investigation for event and deviation

20%:

Internal/ External Document Archival

  • Facilitate loan out/ return of internal archived documents

  • Arrange for documents to be external archived, and retrieval

  • Perform yearly red-tag to identify documents to be external archived

  • 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

  • Manage SOPs, Forms and TQs pertaining to the documentation process or related computerized system (i.e. create/ update, format and route for approval, etc)

  • Compile and print JDE Error Report

  • Perform troubleshooting and resolve documentation related issue

  • Support investigation for non-conformance in Documentation area.

  • Perform On-Job-Training to team members for relevant computerized system but

  • not limited to JDE, PRIMR, etc

  • Actively support continuous improvement initiatives

  • Actively support implementation of changes to Documentation

  • Act as a SME (Subject Matter Expert) for improvement projects

10%

Staff Technical Training and Development

  • Meet and maintain training requirements

  • Complete assigned training on time

  • Lead in the development of training material

  • Develop and maintain personal development plan

  • Provide annual performance self-assessment on development plan

Additional:

  • 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

  • Minimum Diploma with 2 - 4 years of relevant experience in Pharmaceutical/ Manufacturing environment or in the related fields

  • Diploma preferably in Chemical Process Development, Biotechnology, Chemistry or equivalent.

  • Effective interpersonal, organization and communication skills, and the ability to work in a multi-disciplinary team

  • Team player, self-driven and able to work under pressure with a sense of urgency

  • Experience in PRIMR/ JDE or equivalent system will be an added advantage

  • Able to take initiative with problem solving skills

  • Excellent team player with hands-on attitude

  • Able to support overtime as required

  • 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.

Key Skills and Competencies

  • Possess good communication skills across all levels

  • Possess good troubleshooting skills

  • Good knowledge in system user of business systems such as JDE, PRIMR and Trackwise, etc

  • Good technical knowledge, and is able to update Standard Operating Procedures (SOPs)

  • Good technical knowledge in administrative support for Manufacturing Standalone equipment

  • Full awareness of current Good Manufacturing Practices (cGMP)

  • Good knowledge in management of SOP, batch records and logsheets

  • Good knowledge of Windows environment such as Excel, Word, and PowerPoint

  • Able to support Continuous Improvement Projects

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.

Locations

SGP - Singapore - Woodlands

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time
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Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

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