Quality Engineer

vor 3 Wochen


Lausanne, Schweiz LHH Vollzeit

For one of our clients, a global leader in biotechnology based between Geneva and Lausanne, we are looking for a Quality Engineer (M/F).

As part of a 9-month project and the launch of a product in the biotechnology market, we are looking for a candidate available immediately (within 1 month maximum). There are possibilities to continue on a permanent contract.

Your Responsibilities:

- Completing manufacturing quality activities related to raw materials, intermediate, and final products.
- Ensuring compliance with operational objectives, statutory and regulatory requirements, and current Good Manufacturing Practice (cGMP).
- Contributing to internal and external audits with knowledge of processes, products, equipment, and applicable Quality Management System standards and regulations.
- Liaising with key staff from other functional areas to achieve required operational output and escalate conflicting priorities as needed.
- Quality Assurance: Release of incoming goods, intermediate, and final products. Ensure accurate recording and completion of relevant documentation.
- Documentation Management: Maintain records of incoming deliveries, batch manufacturing, test records, specifications, SOPs, policies, supplier monitoring files, ERP, and QMS records.
- Metrics and Reporting: Provide monthly metrics for non-conforming material and incoming inspection results.
- Qualification Activities: Manage qualification activities of new and existing equipment/systems.
- Quality Management: Perform non-conformance and change control assessments, facilitate quality meetings, and assist during internal/external audits.
- Continuous Improvement: Identify areas for improvement, contribute to a culture of continuous improvement, and participate in continuous training and assessment.
- Problem Solving: Ensure incidents and deviations are captured, reported, investigated, and root causes established.
- Compliance: Conduct all duties in compliance with GMP, GDP, and appropriate regulatory requirements.

Your Profile:

- Demonstrated secondary level education. Bachelor's degree in science (Pharmaceutical/Biotechnologies) or equivalent is a strong asset.
- Experience: Relevant work experience in a GMP environment and working in controlled environments to relevant regulatory standards (ISO 13485, 98/97/EC IVD Directives, FDA Code of Federal Regulations).
- Good understanding of core IT packages, especially Microsoft Excel.
- Good communication skills and a collaborative approach.
- Effective team player with good time management skills.
- Ability to analyze information and prepare coherent reports.
- Leadership skills and good organizational abilities.
- Fluent in English; French is an asset.
- Available now or within 1 month

#LI-PM1

#LI-Hybrid


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