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CSV/DI & Laboratory Equipment Qualification Specialist

Neuchâtel, Switzerland


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CSV/DI & Laboratory Equipment Qualification Specialist

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Job ID SR0038573 Date posted 07/11/2019 Location Neuchâtel, Switzerland

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

An exciting and challenging opportunity has become available at Takeda Neuchâtel Plant (approx. 650 employees) for a Quality Control Equipment Qualification Specialist.

This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the Quality Control teams within a world-class Biotech GMP manufacturing environment.

Job summary

The job holder is accountable for the laboratory instruments qualification, including Computerized System Validation (CSV) in the QC laboratories of Neuchâtel - Switzerland. In addition, the job holder also supports the deployment of Data Integrity (DI) in the department.

Essential duties and responsibilities

  • Ensure computerized system validation strategy within QC department as well as providing laboratory equipment validation expertise
  • Comply with GMP and Data Integrity requirements through applicable guidelines and procedures
  • Define and follow-up the CS Validation Strategy (Validation Plan)
  • Review / Approve User System Requirement (URS), Functional Specification and Design Specifications
  • Lead Risk Assessments
  • Write Design Qualifications
  • Writing qualification protocols (IOPQ) and reports for quality control instruments, including computerized systems
  • Ensure the readiness of instruments for validation activities (i.e. with feasibility protocols)
  • Support analytical technical transfer of assays requiring Analytical Instrument Qualification activities (AIQ)
  • Oversee qualification activities executed by QC analysts, provide training and support
  • Coordinate instruments periodic review
  • Support and prepare inspections, audit responses and regulatory submissions

Education & Experience

  • Bachelor or engineering degree in a technical field
  • Min 3 years of experience in Analytical Instrument Qualification (AIQ) and Computerized System Validation (CSV) activities
  • Experience in GMP laboratory activities and good knowledge of Data Integrity requirements
  • Fluent in French and English (C1 written and spoken)


  • Excellent computer skills (Word, Excel, Power Point, MS Project)
  • Able to set his/her own priorities and tight timelines
  • Good interpersonal, organizational, and communication skills
  • Ability to synthesize information and defend conclusions publically

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 SR0038573

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