Quality Assurance Expert for QC and Engineering
Our Pharmaceutical client located in Neuchatel is looking for a highly motivated Quality Assurance Expert to join the team dedicated to providing quality oversight for engineering and project activities related to the Quality Control laboratory of biologic products.
This is an exciting career opportunity for a dynamic, autonomous, rigorous, and change-agile quality professional to embrace a team-based culture in a world-class Biotech manufacturing environment.
End Date : 21.11.2025 (extension is possible)
Language requirement: French (Fluent), English (nice to have)
Your mission
As QA Expert, you will report directly to the QA Manager and be responsible for compliance and quality oversight and validation aspects related to laboratory projects.
The QA Expert is the representative for both routine GMP (Good Manufacturing Practices) activities and projects. He/she must ensure the quality of information reported within the various systems and documentation with respect to current guidelines, compliance, and regulatory requirements.
* Review and evaluate change requests according to procedures, GMP requirements, and licenses.
* Act as the Quality partner for QC Laboratory Projects.
* Act as Quality Representative for facility projects to support the quality system deployment and application to meet the current Regulatory Requirements.
* Execute guidelines and Regulatory cGMP requirements in the respective Quality area.
* Responsible for quality aspects during the validation activities: review validation deliverables (i.e., validation plan, protocols, reports, URS, design qualification, risk assessment...).
* Define and challenge validation approaches to be compliant with current regulations.
* Lead and/or review deviations in the framework of events during the project (i.e., Trackwise) to verify acceptability and adherence to standard procedures and regulatory requirements. This includes conducting or approving the relevant investigations, impact assessments (related to impact on concerned equipment/product/material), and definition of relevant CAPA.
* Provide feedback on project activities using proactive communication.
* Prepare, evaluate, and approve controlled documentation revisions.
* Report findings/issues to functional leaders and higher management as needed.
Required Skills
* Knowledge of FDA, EMA, ICH, Pharmacopoeia regulations, ISO Quality system standards, and data integrity principles.
* Knowledge and interest in QC equipment/systems.
* Knowledge in CSV and QC equipment/systems validation.
* Background in QC GMP testing on biopharmaceutical products.
* High affinity for digital technology.
* Autonomous, structured, rigorous, and self-motivated.
* Solution-oriented, pragmatic, ability to simplify complexity.
* Able to manage priorities in a fast and dynamic environment with a strong emphasis on maintaining high-quality standards.
* Team player, prepared to work in a team-based culture.
* Demonstrate excellent communication skills (oral and written), ability to adapt to the audience.
* Fluent in French.
* Oral and written skills in English, fluency is an asset.
Education & Experience
* Bachelor/Master degree or equivalent in Engineering, Biotechnology, Pharmacy, or Quality Management applied to industrial processes.
* 3-5 years minimum of experience within a GMP environment, biotech/pharmaceutical company.
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