Posted to MedZilla on 9/23/2019


Takeda Pharmaceuticals

Singapore-, Dispensing & Logistics Technician II SR0040017-MZ


 
 

Primary Objective of this Role:

  • With general supervision the individual will perform routine manufacturing operations which also include area of Shipping, Warehousing and Sampling activities. Operates production equipment according to Standard Operating Procedures (SOPs), Process Control System (PCS), Electronic Batch Records (EBM), Master Formulation Record (MFR), Checklists/Forms for the production of commercial and/or clinical products and waste disposal. Perform manufacturing operations according to EHS guidelines and in a cGMP compliant manner.

Responsibilities

The individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Electronic Batch Records (EBM), Batch Records and Forms. Primary responsibilities include:

  • Perform routine and non-routine dispensing operations as per MFR/EBM (If required)
  • Perform well-defined SOPs
  • Execute instructions and record data in the EBM system
  • Transfer materials from warehouse staging area.
  • Weigh and dispense raw materials required for batch processing.
  • Respond to any non-routine request from Manufacturing floor
  • Transfer materials/consumables required for production from level-1 to level-3 production area.
  • Perform wipe down and sanitization of materials/consumables for production use
  • Perform cleaning and sanitization of work area and equipment
  • Manage and maintain weighing and dispensing tools and equipment
  • Perform disposal of packaging materials and production wastes
  • Write and revise SOPs and manufacturing records
  • Perform troubleshooting and carry out first fix for equipment issues
  • Actively support transfer of new processes and commission/validation of new projects
  • Support GMP and Safety audits
  • Mentor and train team members on-the-job
  • Attain adequate operating knowledge of the Process Control System (PCS)
  • Attain adequate operating knowledge on the Manufacturing Execution System (MES)
  • Record data into logbooks, log-sheets and forms (If applicable)
  • Perform logbooks and log-sheets review and follow up
  • Perform monitoring for process and equipment performance during operation as per SOP/MFR
  • Demonstrate cleanroom technique in the handling of product and materials
  • Perform basic 5S housekeeping
  • Guide and perform On-Job-Training to team members
  • Support Alarm/Alert review and real time trouble-shooting
  • Support troubleshoot and resolve process related issues
  • Support investigation to event and deviation
  • Interface with other departments to resolve issues related to daily operations
  • Actively support transfer of new processes and commission/validation of new projects
  • Support GMP and Safety audits
  • Involve in hands-on execution of the plant operations and assist Supervisors in trouble-shooting
  • The individual will be operate in at least 2 areas of warehouse operations; namely receiving/inspection/storage, kitting of BOMs, sampling of materials and shipment.
  • Responsible for warehouse-related duties such as receiving, storage and transfer of materials and inventory
  • Competent in expiration dating of received materials and management of Expired Materials.
  • Prepare and coordinate shipments, including packing and preparation of shipping documents
  • Management of Templates and competent in reading template reports
  • Handling of equipment and goods, including Hazardous Materials, with strict adherence to safety guidelines and company procedures
  • Perform necessary transactions in the company s ERP system through handheld devices and computers
  • Assist in Troubleshooting for JDE, DC Link and LIMS issues
  • Pull samples from delivered material as necessary, in accordance to the company s sampling procedure
  • Participation in Raw Material Release Issues resolution
  • Involvement in stock counts/checks and 5S activities
  • Adhere to applicable SOPs/policies
  • Responsibility to adhere to any applicable EHS requirements.
  • Commitment to a fair and respectful relationship to others and behavior in accordance with Shire s Code of Conduct.

The individual will manage equipment and support facility related projects by

  • Support routine safety and GMP walk down and responding to findings (If required)
  • Support execution of Corrective/Preventive actions which identified (If required)
  • Support change control activities when assigned (If required)

Staff Technical Training and Development

  • Meet and maintain training requirements
  • Complete assigned training on time
  • Provide technical training for area personnel
  • Provide input on training material development
  • Provide annual performance self-assessment on development plan

Education and Experience Requirements

  • Diploma in Applied Chemistry / Biomedical Sciences / Chemical Engineering / Food Science & Technology / Biologics & Process Technology / Chemical & Pharmaceutical Technology/ Food Science & Nutrition / Molecular Biotechnology / Biotechnology / Chemical & Biomolecular Engineering / Pharmacy Science or related with up to one year of relevant experience in the biotechnology, pharmaceutical industry, warehouse/logistics operations
  • Min GCE N , O or ITE / Nitec in Biotechnology / Chemical Process Technology or related with up to three years of relevant experience in the biotechnology, pharmaceutical industry, warehouse/logistics operations
  • Demonstrate commitment to cGMP, EHS compliance aspects of clean-room plant operation
  • Experience in ERP/MES/control systems applications will be an added advantage
  • Able to take initiative with good problem solving skills
  • Excellent team player with hands-on attitude
  • Able to work on rotating shifts
  • Able to support overtime as required
  • Able to support production demands with adjusted work schedule
  • Able to adhere to EHS/GMP requirement
  • Ability to wear appropriate PPE/Cleanroom gowning as per SOP
  • Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.
  • Ability to lift, pull or push equipment requiring up to 20kg
  • Able to work in cold environment (2 to 8 degree C)
  • Able to climb ladders and work on platforms
  • Able to perform confine space entrant/attendant (If required)
  • Frequent need to read and reference documents to complete tasks
  • Forklift certification and experience in operating a reach truck
  • Physically fit to perform some carrying, lifting and cleaning
  • Routinely work in conditions requiring the use of Personal Protective Equipment (PPE).

Key Skills and Competencies

The individual should have moderate understanding of general job aspects and detailed aspects of the job.

  • Possess good communication skills
  • Possess basic documentation and computer skills
  • Possess basic troubleshooting skills
  • Trained in using warehouse equipment
  • Able to perform assigned warehouse processes in at least 2 areas of operations while observing company procedures and good documentation practices.
  • Operate with general supervision in at least 2 areas of warehouse operations.
  • Has initiative, is responsible and able to collaborate with other functions
  • Familiar with current Good Manufacturing Practices (cGMP)
  • Ability to read/understand Safety Data Sheet (SDS) and handle chemicals as per SOP
  • Ability to monitor and analyze processing parameters and report atypical trends
  • Ability to support Continuous Improvement Projects

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.


Please visit our website at takedajobs.com

 
 


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