Posted to MedZilla on 9/17/2019

Takeda Pharmaceuticals

Singapore-, QC MI&S Specialist SR0039725-MZ


Primary Objectives of this Job

  • This position is required to perform all tasks associated with the Global QC lab operations which include deviation/investigation write up/review, equipment qualification, method validation, method transfer and other tasks as assigned.


Validation of Method, Analytical Equipment and Software

  • Write validation Protocols, Technical Reports, Deviation Reports.
  • Plan validation activities with local QC
  • Assures GMP compliant and timely execution of validations
  • Coach/lead validations (incl. S&R and CC), focus on complex topics, involving other sites/functions outside QC
  • Establish and maintain validated status of assays and equipment
  • Subject matter expert in instrumentation and technical functions e.g. method validation/transfer, lab equipment etc.
  • Provide technical advice to Local QC in laboratory related troubleshooting, e.g. lab equipment failure

Other Responsibilities

  • DP site SME (local training, communication site/DP owner)
  • Perform trending for laboratory invalid tests
  • Lead and drive investigations (OOS, Lab invalids, etc)
  • Identify, lead and drive improvements or remediation of assays
  • Leads problem solving and improvement projects for troubled assays (OOS, CAPA, etc)
  • Knowledge sharing of problems that found and share solutions to drive continuous improvement
  • Provide training and consulting
  • Prepare documents for qualification plan/ report and calibration plan/report for S&R as required
  • Prepare control assignment Protocol/Report for controls as required.
  • Support audit preparation, present investigation/issues and MI&S documents at audits as required.
  • Prepare/ revise regulatory submission documents and MoH responses e.g. CVR (Consolidated (Test) Validation Report) and annual report as required
  • Maintain the schedule for compendia reviews

General Responsibilities

  • KPI fulfillment and Support global harmonization and simplification
  • Coordinates a subset of team members or entire group for specific tasks/topics/projects
  • QC specialist may cover for another QC specialist of similar functions/areas in his/her absence signing documents on his/her behalf.
  • 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.

Education and Experience Requirements

  • Bachelor Degree in Chemistry, Biochemistry, Biotechnology or equivalent
  • At least 1 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment.
  • Six Sigma Greenbelt training would be helpful.
  • Demonstrated strong technical experience e.g. in the area of method validation, method transfer, equipment qualification, OOS investigation.
  • Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

Key Skills and Competencies

  • Experienced validation know-how, independent lead/Decision driver within validations/investigations
  • Team player and independent contributor
  • DMAIC tools experience
  • Presentation skills for training and audits and Senior Management
  • Experience in problem solving (facilitation and application of tools)
  • Basic statistical knowledge and experience with data analysis
  • Knowledge concerning cGMP, especially lab related topics as method validation, OOS, critical reagent qualification, equipment and software validation life cycle
  • Basic knowledge about regulatory requirements concerning analytical test methods and licenses
  • Has substantial knowledge and understanding in terms of regulatory standards requirements e.g. USP, EP, 21CFR, ICH etc.
  • Knowledge in Microsoft Office
  • Project Management Skills
  • Communication and organizational skills
  • Strategically and Business oriented thinking

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.

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