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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.
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