Job Description

By clicking the \xe2\x80\x9cApply\xe2\x80\x9d 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\xe2\x80\x99s and . I further attest that all information I submit in my employment application is true to the best of my knowledge.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\xe2\x80\x99s Biologics Operating Unit network, the site is Takeda\xe2\x80\x99s only biologics drug substance manufacturing facility in Asia. The facility has two buildings, including manufacturing suites and laboratories, as well as Takeda\xe2\x80\x99s first positive energy building certified by Singapore\xe2\x80\x99s Building and Construction Authority\xe2\x80\x99s Green Mark scheme in 2022.Job Title: Documentation Specialist III
Location: Woodlands, SingaporeAbout 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, etcMaintain 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 contribute70%: 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 formsAttain in depth operating knowledge in PRIMR, LIMS, JDE and EBM transaction, etcPerform data interface with PRIMR but not limited to entry, verification, data editing, etcPerform JDE transaction but not limited to materials consumption, verification, work order completion (including WO08/11), KU adjustment, etcAttain in depth knowledge in trouble shooting and rectification of JDE/ XPF errorsPerform Inventory Adjustment (Scrap/discard)Perform materials transactions of non-work orders (IE) processArchive completed MBR/MFRReview MBR/MFR issuance and movement logPerform updating of electronic tracking logCollaborate closely with other departments to resolve issues related to daily operationsControlled Copy/ Logbook ManagementCheck/ verify number of the controlled copies that are effective dailyPrint controlled copies and replace superseded copies in the manufacturing areaRemove obsolete controlled from manufacturing areaPerform issuing and archival of logbook timelyOther Documentation SupportFormatting of Manufacturing and Engineering documentsIssuance of Ad-hoc labels (Cleaning Monitoring/ In-Ops/ DHT, etc)Support for printing of LIMS labels and forms for water samplingAudit SupportLead and Support investigation for event and deviation20%:Internal/ External Document ArchivalFacilitate loan out/ return of internal archived documentsArrange for documents to be external archived, and retrievalPerform yearly red-tag to identify documents to be external archivedPerform 5S inspectionAdministrative 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 equipmentPerform Annual User reviewRoutine time synchronization of systemRoutine backup and archival of dataExecution of protocol/ test script requiring administrative accessOthersManage 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 ReportPerform troubleshooting and resolve documentation related issueSupport investigation for non-conformance in Documentation area.Perform On-Job-Training to team members for relevant computerized system butnot limited to JDE, PRIMR, etcActively support continuous improvement initiativesActively support implementation of changes to DocumentationAct as a SME (Subject Matter Expert) for improvement projects10%Staff Technical Training and DevelopmentMeet and maintain training requirementsComplete assigned training on timeLead in the development of training materialDevelop and maintain personal development planProvide annual performance self-assessment on development planAdditional:Responsibility to adhere to any applicable EHS requirements.Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda\xe2\x80\x99s Code of Conduct.Any other duties as assigned by supervisor.What you bring to Takeda:Education and Experience RequirementsMinimum Diploma with 2 - 4 years of relevant experience in Pharmaceutical/ Manufacturing environment or in the related fieldsDiploma preferably in Chemical Process Development, Biotechnology, Chemistry or equivalent.Effective interpersonal, organization and communication skills, and the ability to work in a multi-disciplinary teamTeam player, self-driven and able to work under pressure with a sense of urgencyExperience in PRIMR/ JDE or equivalent system will be an added advantageAble to take initiative with problem solving skillsExcellent team player with hands-on attitudeAble to support overtime as requiredAble to adhere to EHS/GMP requirementAble to support production demands with adjusted work scheduleAbility to wear appropriate PPE/Cleanroom gowning as per SOPAbility to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.Key Skills and CompetenciesPossess good communication skills across all levelsPossess good troubleshooting skillsGood knowledge in system user of business systems such as JDE, PRIMR and Trackwise, etcGood technical knowledge, and is able to update Standard Operating Procedures (SOPs)Good technical knowledge in administrative support for Manufacturing Standalone equipmentFull awareness of current Good Manufacturing Practices (cGMP)Good knowledge in management of SOP, batch records and logsheetsGood knowledge of Windows environment such as Excel, Word, and PowerPointAble to support Continuous Improvement ProjectsMore 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.LocationsSGP - Singapore - WoodlandsWorker TypeEmployeeWorker Sub-TypeFixed Term (Fixed Term)Time TypeFull time

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