Scope

We assist our clients through non-clinical and clinical studies to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.

For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.

Quality Assistance is always focusing on meeting customer expectation through the continuous improvement of the operational processes and the culture of the organization.

In order to achieve operational excellence and coordinate our company continuous improvement initiatives we are looking for an Operational Excellence Specialist.

Your mission

You will be part of a team and report to the Scientific Operations Director

In this role and together with team members you will be involved in operational excellence projects and contribute to the improvement of the company performance.

You will be accountable for:

Identifying process improvement opportunities and translating these needs into specific projects:

  • Work closely with key stakeholders across functions to collect data

  • Propose corrective actions  

  • Participate in continuous improvement projects related to lab processes

  • Ensure projects follow-up with clear metrics

  • Write related documents: reports, procedures, …

Your profile

Bachelor or Master’s degree in Science

Required:

  • A first work experience in a regulated environment (for example: GxP environment)

  • Knowledge of Lean or Six Sigma tools

  • Ability to promote “Lean Thinking” 

  • Team Player and very good communication skills

  • Data analysis ability 

  • Very good organisational and reporting skills

  • Fluent in French

  • B1 level of English (writing and listening)

Pluses:

  • Knowledge of Root Cause Analysis tools  

  • Good knowledge of Excel (complex tools for data analysis as charts, PivotTables, VBA)

  • Good knowledge of Power Point

Why join Quality Assistance?

We are a true career partner.

  • We accelerate people’s access to new medicines.

  • We offer an inspiring work-life balance in a human scale environment.

  • We care about mutual respect, assistance and communication.

  • We listen to your needs and your suggestions.

  • We offer a market-competitive remuneration package including numerous fringe benefits. 

Visit https://www.quality-assistance.com/quality-assistance/life-quality-assistance to learn more.

About Quality Assistance

Quality Assistance is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products.

We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences. 

For each client project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.

The company holds a unique position on the market with all its laboratories on one site, 220 highly qualified professionals and over 35 years’ expertise at the forefront of analytical sciences.

The Quality Assistance environment is GMP, GLP and GCLP/GCP compliant.

Visit https://www.quality-assistance.com/quality-assistance/leading-analytical-cro to learn more.

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