Senior Quality Assurance Specialist
vor 4 Wochen
Quality Operations Senior QA Specialist
Talent acquisition is a key aspect of Lonza’s success and we are currently looking for a Senior QA Operations Specialist to join our team. In this role, you will be responsible for managing 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 facilities.
- Provide quality oversight regarding contamination prevention risks and controls.
- Lead 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.
- Participate 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.
- 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.
Key Requirements:
- Bachelor, Master’s degree, or PhD in chemistry, biotechnology, life science, or a 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, with good German skills advantageous.
At Lonza, we believe that our success is built on the dedication and expertise of our people. We are committed to providing a safe, inclusive, and rewarding work environment that supports the well-being of our employees and their families.
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