QA Expert Manufacturing (80 - 100%)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Senior Quality Assurance Specialist Manufacturing.
- Perform batch release for aseptic manufactured drug product
- Write, review and approve deliverables (e.g. procedures, SOPs, cleaning documents, gap assessments) and related data bases (e.g. training, validation) to ensure GMP compliance
- Ensure that the corresponding elements of the corporate Lonza GMP Quality Manual are appropriately implemented and followed
- Document review and approval including documents in electronic systems like MES (e.g. batch records)
- Advice line functions concerning product and process related topics.
- Approve change requests, deviation and CAPAs related to product and process
- Promote and enforce compliance to internal and external guidelines regarding quality and safety
- Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans
- Lead activities like Development/evaluation of new tools, processes, quality initiatives, quality plans, training activities
- Support project management functions as sub-team member or in preparation for registrations
- Provide support to Sterile Production Stein line functions in GMP compliance related issues in area of Specialists
- Write/Contribute to internal compliance policy and/or comment to regulations. Management and reporting of KQIs
- Represent Sterile Production Stein QA in inspections, audits and local and global initiatives
- Ensure support for global initiatives (e.g. quality alerts, global procedures)
- Academic degree (Master or higher) in Natural Sciences, Pharmaceutical Sciences or related field
- Extensive working experience in Quality Assurance in pharmaceutical industries and GMP controlled environment preferable in sterile Drug Product production
- Profound knowledge in aseptic manufacturing of chemical and biological drug products
- Sound knowledge of written and spoken German and English is required, French is an advantage
- Shop-Floor QA experience in Quality Oversight is an advantage
- Excellent communication skills; Coaches and inspires people to achieve team goals
- Excellent decision making skills
- Excellent ability to provide solutions for complex challenges
- Experience in electronic batch record system is an advantage
- Ability to work independently as well as in a team environment
- Detail oriented, precise and organized
- Good inter-personal skills
- Energized and open-minded
- Willingness to learn and carry out new and complex tasks
- Proactive attitude
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.