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Documentation Specialist Iii

2 weeks ago

Singapore Takeda Pharmaceutical Full time

**Job Title: Documentation Specialist**
**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**:

- 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.
- 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.

Primary responsibilities include:
(70%)

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- Print controlled copies and replace superseded copies in the manufacturing area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
- Support investigation for event and deviation

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

(20%)

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
- Assist in the development of training material
- Develop and maintain personal development plan
- Provide annual performance self-assessment on development plan

**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 att