Critères de l'offre
Métiers :
Quality Engineer
Diplômes :
BA (Bachelor of Arts) / BSc (Bachelor of Science)
+ 1 diplôme
Compétences :
English
French
ISO 13485
Lieux :
Lausanne
Conditions :
Permanent contract
Full Time
L'entreprise : LHH The Adecco Group Switzerland
Plus d'infos sur LHH
Description du poste 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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