Switzerland, Stein
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. And that’s the kind of work we want to be part of.
Responsibilities
You will manage quality oversight for computerized systems validation and the data integrity program & support QA activities for system introduction/upgrades, ensuring compliance with quality policies, cGMP, EU/US, and Swiss regulations. Also, you will oversee daily quality for GxP IT, CSV, and automated systems (SISA). MES, PLC/SCAPA, EMS, LIMS, SAP) for DMS Lonza Stein within a project framework and in accordance with quality policies, GMP, EU/US regulations and Swiss regulations. Furthermore, you will ensure close collaboration with other site functions and you will drive compliance and continuous improvement while supporting Lonza's overall CSV and DI strategy.
* Act as the primary QA contact for data integrity to the assigned area
* Review/approve GxP IT, CSV and SISA SOPs to ensure regulatory compliance
* Ensure compliance with cGMPs and support Commissioning & Qualification activities
* Review/approve CSV related documents, design documentation, audit trails, deviations, investigations and CAPA plans
* Align with Global QA CSV organization and support inspection readiness
* Being an actor in raising the CSV/DI maturity of the site in accordance with the group strategy
* Ensure alignment with Global QA CSV organization
Profile
* Academic degree in natural/applied sciences (Pharmacy, Chemistry, Biotechnology, Engineering)
* Minimum 10 years in CSV/QA CSV with Quality experience
* In-depth knowledge of cGMP, international regulations, and validation activities
* Experience with international inspections
* Strong analytical, problem-solving, and communication skills. Ability to make pragmatic and compliant decision
* Having had experience with software such as TRACKWISE and KNEAT is an asset
* Fluent in English, German is an asset
Inclusion is one of Lonza’s four core values, alongside integrity, innovation and initiative.