Quality Assurance Expert
Takeda
Neuchâtel, Switzerland
vor 1 Tg.

Quality Assurance Expert

Apply Now Job ID SR0034477 Date posted 09 / 03 / 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 Assurance (QA) Expert - Deviation position.

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 teams within a world-class Biotech manufacturing environment.

Job summary

Within this position, the QA Expert is responsible for Quality Assurance in the frame of activities all along the manufacturing and release processes especially for investigations linked to deviations.

The QA Expert is the QA representative for routine deviation activities (impact assessment, risk analysis, problem solving).

She / He has to ensure quality of information within systems and documentation in respect to current guidelines, compliance and regulatory requirements.

The successful candidate should participate to GMP audits and promote Continuous Improvement on site.

Essential duties and responsibilities

  • Participate to the Quality daily activities related to deviation management.
  • Be familiar with the tools used for investigation purposes.
  • Provide quality oversight in term of problem solving / root cause analysis for deviations and CAPA’s.
  • Education & Experience

    University degree in Life Sciences, Biotechnology, Pharmacy, or Quality Management applied to industrial process or equivalent experience in pharmaceutical and / or biotechnological companies.

    Proven knowledge of FDA, EMA, ICH regulations, Pharmacopeias and Quality system standards.

    Previous experience in auditing and regulatory inspections.

    Soft Skills :

    Solution oriented and ability to simplify the complex.

    Good listener, team oriented and good communication skills.

    Good organizational skills and continuous improvement mindset.

    Living our leadership behaviors is a basic expectation for all Takeda employees.

    Takeda expects all employees to embrace the following :

  • Honesty
  • Perseverance
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