Quality Engineer (M/F)

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

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