Senior Quality Assurance Specialist
vor 1 Woche
Quality Operations Senior QA Specialist
Lonza is a global leader in life sciences, operating across three continents. 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.
The Role:
We are seeking a Senior QA to be a member of QA Operations for Mammalian Small Scale (Single Use facility) Drug Substance manufacturing. The successful candidate will be an individual contributor working with multiple stakeholders to manage the quality oversight for contamination control and gap evaluation for internal/ external audit/ inspections.
Key Responsibilities:
- Key contact for Contamination Control Strategy (CCS) related topics for Single Use Mammalian Drug Substance Facility.
- Providing quality oversight regarding contamination prevention risks and controls.
- Leading CCS-related topics for the asset (Bioburden control strategy, hygiene, environmental monitoring).
- Review and approve deviation/investigation related to environmental monitoring excursions in the production area.
- Manage risk and quality oversight for CCS-related topics.
- Participating in the Global Microbial Contamination Control Community to exchange information and best practices as necessary.
- Perform gap assessment for internal/ external audit and inspections.
- Facilitate discussion within internal cross-functional teams (MSAT, Operations, QC etc).
- Review and approve the Standard Operating Procedure (SOP) of the relevant topic associated with the role.
- Involved in customer audits as well as regulatory inspections and supports all activities to ensure inspection readiness of the department.
- Perform other duties as assigned.
Key Requirements:
- Bachelor, Master's degree or PhD in chemistry, biotechnology, life science, or related field.
- Sound years of experience in the GMP area within a pharmaceutical industry (preferably in the mammalian drug substance environment).
- Good knowledge of GMP and regulatory requirements.
- Strong leadership skills; very good communication skills and interaction with all kinds of interfaces within the organization.
- Structured, focused and well-organized working attitude; open-minded to new ideas, agile, highly motivated, and solution-oriented.
- Excellent knowledge of written and spoken English; good German skills advantageous.
Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
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.
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