Quality Assurance Specialist

vor 2 Wochen

Sulz AG, Aargau, Schweiz Lonza Vollzeit
About Lonza

Lonza is a global leader in life sciences operating across three continents. We work in science, but there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.

Job Overview

This role offers the opportunity to join a dynamic team as a Quality Assurance Specialist. As a key member of our GxP IT quality team, you will be responsible for managing quality oversight for computerized systems validation and data integrity program, ensuring compliance with quality policies, cGMP, EU/US, and Swiss regulations.

Key Responsibilities
  • You will oversee daily quality for GxP IT, CSV, and automated systems (SISA) within a project framework and in accordance with quality policies, GMP, EU/US regulations, and Swiss regulations.
  • Ensure close collaboration with other site functions, driving compliance and continuous improvement while supporting Lonza's overall CSV and DI strategy.
  • Act as the primary QA contact for data integrity to the assigned area.
  • Review and approve GxP IT, CSV, and SISA SOPs to ensure regulatory compliance.
  • Evaluate and implement best practices for CSV and data integrity.
Requirements
  • A minimum of 10 years of experience in CSV/QA CSV with quality experience.
  • In-depth knowledge of cGMP, international regulations, and validation activities.
  • Experience with international inspections and software such as TRACKWISE and KNEAT is an asset.
  • Strong analytical, problem-solving, and communication skills, with the ability to make pragmatic and compliant decisions.
About You

We are looking for a highly skilled professional who can bring their expertise to our team. In return, you will have the opportunity to work on challenging projects, develop your skills, and contribute to the success of our company.

An estimated salary for this position is approximately $80,000 - $110,000 per year, depending on qualifications and experience. Please note that this information is based on industry standards and may vary based on location and other factors.

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