Senior QA Specialist for Instrument Qualification at Lonza in Basel. The role focuses on establishing and maintaining equipment qualification systems within the Drug Product Services branch to support patient treatment challenges.
This position sits within Lonza's Drug Product Services branch, which operates across Basel and Stein in Switzerland. The role is designed to help customers address challenges in patient treatment by ensuring rigorous quality standards for equipment and systems.
Responsibilities
- Establishes and maintains the Equipment Qualification System for the DPS division.
- Guarantees that all equipment, instruments, and computerized systems are properly qualified according to the Validation Master Plan.
- Serves as the primary point of contact for equipment qualification and maintenance matters within the QA team.
- Develops overarching documentation for instrument qualification and defines the qualification strategy for complex systems.
- Manages the lifecycle of equipment qualification documents and acts as the first point of contact for related queries.
- Reviews and approves instrument SOPs, qualification protocols, reports, and periodic review documents.
- Addresses compliance issues related to equipment qualification in shared global systems.
- Oversees and carries out compliance activities, including handling non-conformities, change requests, deviations, CAPAs, and audit/inspection observations.
- Fosters a high-performance and trust-based culture, identifies competency gaps, and creates training and development plans.
Requirements
- Bachelor's or Master's degree in natural sciences, or equivalent professional experience.
- Extensive experience in qualifying (computerized) lab instruments, managing quality records, and handling controlled document lifecycles within EU and US GMP regulated environments.
- Familiarity with the ISPE GAMP5 Guide and USP 1058 is required.
- Excellent written and spoken English skills.
What the company offers
- An agile career path and a dynamic work culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
About the company
Lonza operates over 30 sites across five continents, with globally connected teams. The company's core values include Collaboration, Accountability, Excellence, Passion, and Integrity. Lonza values diversity and is committed to creating an inclusive environment for all employees.
- Operates over 30 sites across five continents with globally connected teams.
- Core values include Collaboration, Accountability, Excellence, Passion, and Integrity.
- Values diversity and is committed to creating an inclusive environment for all employees.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.