Documentation Specialist (12 Months Contract)

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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 (12 months contract)

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.

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