QA Specialist (m/f/d) 100%
Randstad (Switzerland) Ltd.
Date de publication :
03 décembre 2024Taux d'activité :
100%- Lieu de travail :Visp
job details
For Lonza AG in Visp we are looking for a QA Specialist (m/f/d) 100%. This role is temporary for a minimum of 6 months.
Lonza in Visp, Switzerland, is one of the company's largest sites and a key hub for innovation and production. The site specializes in the development and manufacturing of pharmaceutical ingredients, biopharmaceuticals, and chemical intermediates. With a broad range of technologies and services, Lonza Visp supports clients in the pharmaceutical, biotechnology, and specialty chemicals sectors, providing tailored solutions for drug and specialty product manufacturing. The site plays a central role in Lonza's global value chain and drives innovation in the life sciences industry.
Key responsibilities:
- Verification of the company's compliance with ISO/cGMP quality system requirements as well as knowledge of PICS Guide to Good Manufacturing Practices
- Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams
- Audit internal quality system elements in manufacturing and operational support areas.
- Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations
- Independently identify and manage special projects or QA compliance functions as agreed upon with QA management
- Review and approve validation documents
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qualifications
- Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience
- GMP compliance and Part 11 compliance knowledge preferred
- Experience with oversight of aseptic processing and the associated international aseptic processing regulations
- Excellent written and oral communication to include accurate and legible documentation skills
- The ability to interface and communicate directly with clients is required
