Loading ...
Loading ...
Senior Professional Global Quality Compliance (f/m/d)
Visualizza: 150
Giorno di aggiornamento: 25-04-2024
Località: Basel Basel-Stadt BS
Categoria: IT - Software
Industria: Human Resources Services
Posizione: Associate
Tipo di lavoro: Full-time
Loading ...
Contenuto del lavoro
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, 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. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.You will support the overall Lonza strategy to gain and maintain the license to operate, lowering quality and compliance risk by performing audit and advising the sites to reach an optimum state of compliance.
Key Responsibilities
- Developing audit agendas based on risk assessment principles drawing on previous audits, current regulatory trends, applicable regulations, any imminent customer submissions and stakeholder input
- Producing timely, detailed and technically correct reports following assessments / audits with appropriate references cited against each observation
- Escalating identified deficiencies and compliance risks to appropriate business, operations and quality heads and, if appropriate, feed into the Operations team for inclusion into Gap Analysis
- Advising and supporting the sites in devising and executing remediation actions to ensure compliance to regulatory and Lonza expectations and requirements
- Approving proposed CAPA / remediation plans, regularly review progress & effectiveness, and continue to give support in all compliance matters
- Completing and maintaining the corporate internal audit / assessment documentation and follow-up / tracking system where applicable
- Master of Science in natural sciences (e.g. Biochemistry, Chemistry, Pharmacy, Microbiology, Biotechnology or equivalent)
- auditing experience in GMP regulated environments, with experience specifically in some of the following: cell and gene therapy, aseptic product, biologics and medical device manufacture
- Experience with health authority FDA, SwissM and MHRA
- Experience in Supplier Qualification and Supplier Monitoring
- Strong understanding of risk assessment and risk management fundamentals / tools
- Excellent English skills, both written and spoken
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Loading ...
Loading ...
Scadenza: 09-06-2024
Clicca per candidarti per un candidato gratuito
Segnala lavoro
Loading ...
Loading ...
LAVORI SIMILI
-
⏰ 28-05-2024🌏 Genève, Genève GE
-
⏰ 28-05-2024🌏 Zürich, Zürich ZH
-
⏰ 28-05-2024🌏 Genève, Genève GE
-
⏰ 28-05-2024🌏 Zürich, Zürich ZH
Loading ...
-
⏰ 28-05-2024🌏 Muttenz, Basel-Landschaft BL
-
⏰ 28-05-2024🌏 Schlieren, Zürich ZH
-
⏰ 28-05-2024🌏 Sarnen, Obwalden OW
-
⏰ 28-05-2024🌏 Zürich, Zürich ZH
Loading ...
-
⏰ 28-05-2024🌏 Zürich, Zürich ZH
-
⏰ 28-05-2024🌏 Zürich, Zürich ZH