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Senior QC Specialist (QC System)

Singapore, Singapore


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Senior QC Specialist (QC System)

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Job ID SR0051650 Date posted 08/05/2020 Location Singapore, Singapore

Primary Objectives of this Job          

This position is a senior specialist role within Quality Control (QC) that is required perform all tasks associated with the QC lab operations which includes:

  • Administration of LIMS Portfolio
  • Coordinator for QC C3ME system
  • QC system administrator Continuous Improvement
  • Support Investigation and Audit


Administration of LIMS Portfolio

  • Management of LIMS / LIMSlink / Business Objects trainings.
  • Develop and Review of LIMS / LIMSlink / Business Objects and their related documents such as SOPs / Exceptions / Protocols / Reports etc.
  • Administration of LIMS Template Maintenance and Instance Data Amendments.
  • Development and Administration of LIMSlink methods and Business Objects Reports.
  • Main Contact as System and Business Expert to assist Global Team and Local Team.
  • Identify and Resolve data quality issues.
  • Work with QC Supervisors to develop a system based (Discoverant, NorthWest Analytics etc.) approach on Real Time trending of QC results.
  • Implement and maintain Real Time trending of QC results to acquire early knowledge within QC Local Test Experts so as to provide site with continuous production surveillance capability.
  • QC Computer System Validation (CSV) Expert.
  • Overall responsible for the roll out of Global QC LIMS program (eg: LABWARE and MODA-EM)

QC Coordinator for C3ME / RAM

  • Overall responsible for the QC C3ME/RAM system coordination with site Engineering C3ME coordinator, internal QC C3ME working team and 3rd party contractors on Asset Management (AM).
  • Responsible in training and advising new C3ME working team members in ensuring monthly Work Orders are closed timely with their respective teams.
  • Point of contact for site Engineering C3ME in ensuring current and future Work Orders forecast to Engineering schedules are planned in accordance to QC schedule.
  • Work with site Engineering C3ME coordinator to meet site C3ME objectives.  
  • Owner for QC C3ME metrics.

QC System Administrator

  • Responsible on User access setup, methods and/or template creation for QC Analytical Instruments.
  • Assist in routine instrument preventive maintenance and calibration activities.

Lead and Drive Continuous Improvement (CI) culture

  • Develop and Drive Lean Laboratory Initiatives and Lead Right First Time within QC with site CI lead.
  • Identify Improvement / Cost-saving Opportunities and potential projects within QC.
  • Track and follow up on-going QC Improvement / Cost-saving Opportunities activities.
  • Adopt a diligent approach to problem resolution within a regulatory context.
  • Develop into a Takeda Blue Belt investigator for QC related investigations (when applicable).
  • Cross functional lead in other investigations within Quality function.

General Responsibilities

  • QC Snr specialist may cover for another QC specialist of similar functions/areas in his/her absence signing documents on his/her behalf.
  • Interfaces with site QC leadership at all levels; Partners with QC head, QC leads and supervisors as part of daily work.
  • Support audit preparation, present QC documents at audits as required
  • 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 Biotechnology, Microbiology, Pharmacy or equivalent.
  • At least 6 to 8 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment.
  • Demonstrated strong project management capability and ability to lead multiple projects.
  • Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

Key Skills and Competencies

  • Advanced Knowledge in Microsoft Office.
  • Keen eye for detailed process steps and identification of gaps / opportunities
  • Strong Planning and Organization Skills
  • Must be detail orientated.

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.

Job ID SR0051650

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