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QA validation expert (9 months)

Neuchâtel, Switzerland

Overview

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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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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QA validation expert (9 months)

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Job ID SR0037083 Date posted 07/04/2019 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.

QUALITY ASSURANCE VALIDATION EXPERT

An exciting and challenging opportunity has become available at Takeda Neuchâtel Plant (approx. 650 employees) for a Quality Assurance Validation (QAV) Expert position  (9 months).

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 Assurance Validation team within a world-class Biotech manufacturing environment.

About the Role

The objective of this position newly opened within the Quality organization is to provide support to the QA Validation in reaching its milestones in a very demanding period with a high volume of projects opened as well as the commitments related to audit observations and at the same time fulfilling their responsibilities on the routine activities. This role is to actively support the QA Validation team on reviewing validation deliverables (validation plan, protocols, reports, URS, design qualification, risk assessment...), supporting projects implementation and routine activities.

Essential duties and responsibilities

Working closely with the Validation, Engineering, Manufacturing, Automation, QA and QA Validation team members, the main responsibilities of the job holder are:

  • Main quality partner of the validation team.
  • Responsible for quality aspects during the validation activities.
  • QA validation representative for both validation routine activities and projects. 
  • Ensure quality of information within validation documentation in respect to current regulations and internal procedures.
  • Involved in the audit GMP as quality partner of the validation team.
  • Responsible for reviewing and approving validation protocols, reports, procedures and other related documents related to cleaning, sterilization, equipment, process, HVAC, utilities, Computerized systems to ensure compliance to internal procedures and regulatory requirements.
  • Review and approval of routine monitoring protocols (CIP, SIP, Temperature control unit)
  • Define and challenge, with the validation team, validation approaches to be compliant with current regulations
  • As the QA validation representative in projects: ensure the quality validation aspects are respected within project, raise the compliance gaps to the QA Validation manager
  • Evaluate and approve deviations related to validation protocols in order to guarantee proper tracking/documentation of the incidents and identification of corrective actions.

Required Skills

  • University degree in Bioscience / Engineering / Biotechnology
  • At least 5 years of experience in quality biotechnology manufacturing and/or pharmaceutical industry, preferably both
  • Experience in validation (CIP, SIP, HVAC, Process, utility, Computerized system)
  • Fluent in French
  • Professional English level is required as most of documents to review are in English
  • Good knowledge of FDA, EMA, ICH regulations and Quality system standards.
  • Ability to interact with all types of personalities in an effective and diplomatic manner. 
  • Critical thinking and demonstrated problem solving / root cause investigation skills
  • Good analytical skills and ability to simplify the complex.
  • Good organizational skills and continuous improvement mind.
  • Autonomous, reactive and flexible

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 SR0037083

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