Senior Quality Assurance Specialist
vor 4 Wochen
Quality Operations Senior QA Specialist
Lonza is a global leader in life sciences, operating across three continents. Our success is built on talented people working together to devise innovative solutions that help businesses improve lives. In exchange, we empower our people to own their careers, driving meaningful impact through their ideas and contributions.
The Role:
We seek a skilled Senior QA Specialist to join our team in Mammalian Small Scale (Single Use facility) Drug Substance manufacturing. As a key member of QA Operations, you will work with multiple stakeholders to manage quality oversight for contamination control and gap evaluation, ensuring compliance with regulatory requirements.
Key Responsibilities:
- Lead contamination control strategy (CCS) related topics for the Single Use Mammalian Drug Substance Facility.
- Provide quality oversight on contamination prevention risks and controls.
- Develop and implement CCS-related topics, including bioburden control strategy, hygiene, and environmental monitoring.
- Review and approve deviations/investigations related to environmental monitoring excursions in the production area.
- Manage risk and quality oversight for CCS-related topics.
- Participate in the Global Microbial Contamination Control Community to exchange information and best practices.
- Perform gap assessments for internal/external audits and inspections.
- Facilitate discussions within internal cross-functional teams (MSAT, Operations, QC, etc.).
- Review and approve Standard Operating Procedures (SOPs) relevant to the role.
- Support customer audits and regulatory inspections, ensuring inspection readiness of the department.
- Perform other duties as assigned.
Key Requirements:
- Bachelor's, Master's, or PhD in chemistry, biotechnology, life science, or a related field.
- Sound 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, excellent communication skills, and interaction with various 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. We respect and protect our people and our environment, achieving business results with integrity and ethics. Join us in improving lives worldwide by developing new ideas and solving complex problems in life sciences.
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