Lead QA Specialist
vor 2 Wochen
Location: VISP
Working Model: Hybrid (3 days in the office, 2 days WFH)
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 Role:The QA Infrastructure and Logistics group provides key QA oversight and support for the Switzerland-VISP site. This group supports the site utilities, warehousing, and movement of raw materials and products in and out of facilities. This position will focus on implementing and managing robust cross-functional support of legacy and new facilities. You will be responsible for assuring Quality Assurance of Lonza’s sites and facilities, whilst ensuring shared utility systems and logistics areas are carried out by Lonza's standards, industry best practices, and the requirements of national and international regulatory agencies.
Role Responsibilities:- Provide QA support for Project and Operations internal customers in the following areas:
- GMP & Compliance
- Cold-chain
- Supply chain
- Good warehousing practice
- Clean utilities
- Provide Quality Assurance oversight to the site and facilities focusing on shared utility systems and logistics areas.
- Organize and lead Deviation Review Boards for Utilities & Logistics related deviations.
- Review and assess Change Requests and Corrective and Preventative Actions (CAPA).
- Review and approve standard operation procedures for shared utility systems and logistics.
- Review and assess GMP impact of utility and cold-chain alarms and incidents.
- Assist with operational readiness activities and assess their risks in the relevant areas.
- Support internal and external audits, and inspections and represent the Quality function at relevant meetings.
- Leads or supports local implementation of global Quality policies and standards in his/her area of responsibility.
- Academic degree (Bachelor or higher) in Pharmaceutical Sciences, Biochemistry, Engineering, Chemistry or related field.
- Relevant work experience in Quality Assurance and/or Production, Engineering, and/or Quality Control in pharmaceutical industries and cGMP-controlled environments.
- Knowledge of Swiss, EU, and US GMP regulations relevant to audit/inspections and compliance systems.
- Strong verbal and written communication skills (English required, German is helpful).
- Ability to communicate quality and compliance requirements to varying levels and functions of the organization.
- Strong collaborative mindset and the ability to build relationships quickly.
- Strong organizational skills, and ability to balance multiple priorities simultaneously.
- Ability to solve problems, understand details and strategic picture, providing practical solutions.
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: R61639
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