QA Manager Support Ibex
We have recently been confirmed as the global manufacturing partner for Moderna’s vaccine against the novel coronavirus, providing a tenfold manufacturing capacity increase. As other businesses face increasing economic uncertainty, we are fortunate to have opportunities for expansion. Through this new collaboration, our work will have a significant, direct and long-term impact on the management of this global pandemic. Become part of this exciting opportunity and join our team by applying for the position as Quality Assurance Manager for Cleaning Validaiton.
In Visp we are looking for a QA Manager Support Ibex IBEX™ to extend our team.
- Review and approve SOPs, Master batch records, recipes and work instructions related to all inter-departmental QA activities e.g. Logistics, material management and utilities.
- Review and approved deviations, changes controls and investigations within the scope of support activities mentioned above
- Oversight of QA activities related to GMP utilities (Clean steam, Purified water, product gases and others)
- Responsible to drive Corrective And Preventive Actions and effectiveness check items to completion and timely closing
- Evaluate relevant changes, assess relevance to regulatory filings, provides change notifications for endorsement to customers where required and approves the change requests
- Support and approve project/product specific risk assessments
- Be involved in and support internal and external audits (incl. inspections by health authorities)
- Bachelor, Master degree or PhD in chemistry, biotechnology, life science or related field.
- relevant experience in the pharmaceutical industry, preferably in a QC or QA function
- Founded analytical expertise and experiences with analytical method validations
- Strong background in cGMP regulations, incl. USP, European and Japanese Pharmacopoeia
- Experienced in the interaction with health authorities (FDA, Swissmedic, etc.).
- Ability to oversee project execution to identify non-compliance from quality standards
- ideas and suggestions; agile, highly motivated and dynamic drive.
- Excellent verbal and written communication in English; German language knowledge is advantageous
Every day, 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.