Quality Management Processes
Vor 6 Tagen
Switzerland, Basel**Key responsibilities**:
- Ensure GxP relevant Corporate QM Systems are in validated state in accordance with established validation framework.
- Act as Quality Partner for Business, System Owner and IT including
- Drive validation activities and support creation of validation deliverables during project
- Cooperate with Business, System Owner and IT, participate in the operational activities.
- Act as validation SME for internal / external audits and regulatory inspections.
- Contribute to validation framework development and ensure alignment with up to date regulatory requirements
- Support development of quality and validation policies, risk-based standards, and procedures in line with internal and external regulations
**Key Requirements**
- Bachelors M.Sc. Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences or related field
- Work experiences in similar positions in pharma industry
- Deep understanding of computerized QM systems, including document, quality and learning management systems design
- Experience in quality oversight of computerized systems in regulated environment
- Work experience with complex system validation documentation creation and maintenance and interest in working with documentation
- Experience in Computerized System GMP Compliance and Data Integrity
- Excellent communication and presentation skills in English - verbal and written, other languages is a benefit
- Strong analytical skills including process and system mapping abilities
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
**Reference: R55577**:
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