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.

Responsibilities

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.


Please visit our website at takedajobs.com

 
 


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