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Quality Control Validation Specialist (2 years duration contract)

Apply Now Email Me Job ID SR0032651 Date posted 02/04/2019 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 Validation 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 validation and the transfer of analytical and microbiological assays performed in the QC laboratories of Neuchâtel - Switzerland. In addition, the job holder also supports laboratory equipment qualification.

Essential duties and responsibilities

  • Comply with GMP and Data Integrity requirements through applicable guidelines and procedures
  • Responsible for writing validation protocols and reports for analytical and microbiological methods
  • Responsible for writing qualification plans and reports for critical reagents and reference standards
  • Oversee validation and qualification activities executed by local QC, provide training and support
  • Responsible for analytical method transfers between Analytical Development and Quality Control laboratories as well as within Operations
  • Support laboratory equipment qualification and ensure the readiness for validation activities (i.e. with feasibility protocols)
  • Write assignment plans and reports for method controls, establish and perform evaluation of control charts
  • Support and preparation of audits, audit responses and regulatory submissions

Education & Experience

  • University or engineering degree in analytical chemistry, biochemistry or biotechnology
  • Min 3 years of experience in GMP pharmaceutical business activities
  • Experience in GMP laboratory activities, preferably with a good knowledge of Data Integrity requirements
  • Good knowledge of analytical method validation and critical reagent qualification
  • Good knowledge of regulatory requirements concerning analytical test methods and licenses
  • Fluent in French and English (C1 written and spoken)

Qualifications

  • Excellent computer skills (Word, Excel, Power Point, MS Project)
  • Knowledge of advanced statistical tools (i.e. sample size determination, control charting, capability, and design of experiments)
  • Able to set his/her own priorities and tight timelines
  • Good interpersonal, organizational, and communication skills
  • Ability to synthesize information and defend conclusions publically

Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following:

  • Integrity
  • Fairness
  • Honesty
  • Perseverance

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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