Senior QC Specialist (QC System)
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.
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Senior QC Specialist (QC System)Apply Now
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.
- 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