- Write, review and/or approve deliverables (e.g. procedures, SOPs, cleaning documents, batch documentation, gap assessments, change request, deviation and CAPA) and related data bases (e.g. training, validation) to ensure GMP compliance.
- Support project and maintain Sterile Production Stein line functions in GMP compliance related issues.
- Promote and enforce compliance to internal and external guidelines regarding quality and safety.
- Lead development and evaluation of new tools, processes, quality initiatives & plans, actively participate in continuous improvement.
- Represent Sterile Production Stein QA in inspections, audits and local and global initiatives.
- Ensure internal and customer support in regards to global initiatives (e.g. quality alerts)
- University or academic degree (e.g. Master) in Chemistry, Biology, Pharmacy or equivalent
- Professional experience in Quality Assurance or Quality Control in a manufacturing environment within Pharmaceutical Industry > 7 years
- Excellent knowledge of cGMP regulations
- Sound knowledge in manufacturing of chemical and biological drug products
- Problem solving skills
- Sets clear priorities for task for him
- Customer oriented and collaboration with Process Unit team
- Ensuring cGMP and regulatory compliance of all relevant operations in the Process Unit
- Excellent English skills (spoken and written) German is an advantage
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QA Expert Manufacturing Release 80-100% - Stein, Schweiz - Lonza
Beschreibung
Senior QA Expert Manufacturing Release 80-100%
Location – Stein, Switzerland
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.
The primary purpose of the role is to ensure a Right Time in Inspection Readiness for a Big CAPEX project (encompassing a Fill Finish Facility, Laboratories, Warehousing, Shipment and Offices). The role will manage QA operational activities to support departmental projects and objectives according to agreed timelines and standards and ensure compliance with GMP is maintained in Sterile Production Plant Stein. Then, after the project phase, will manage the quality activities as operational QA (e.g. Batch Release, deviation, etc.)
Key Responsibilities:
Key requirements:
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: R59178
