Quality Engineer

Vor 7 Tagen

Lausanne, Schweiz TN Switzerland Vollzeit

Social network you want to login/join with:

Quality Engineer (M/F), Lausanne DistrictClient:

LHH

Location:

Lausanne District

Job Reference:

5e1cc167d104

Job Views:

7

Posted:

03.03.2025

Expiry Date:

17.04.2025

Job Description:

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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