For our customer located in Basel/Switzerland we are currently looking for a: CSV QA Lead (m/f/d)
- Location: CH-Basel/Kaiseraugst
- Branch: Pharma
- Duration: asap – 31.08.2024
Tasks & Responsibilities
- Being responsible for ensuring the project is compliant with CSV Policies and external regulations (FDA CFR Part 1, 21 CFR part 820.70, EudraLex Annex 11, etc.,)
- Being responsible for reviewing and approving Global CSV (planning, requirements, specs, testing, reports) documents related to system retirement or separation due to the divesting of a manufacturing site
- Providing Quality Assurance guidance as well as strategic work package planning to the IT validation team
- Providing weekly written updates to Quality leadership
Must Haves
- Senior IT background with science understanding – at least 5 years of experience in CSV
- Expert in Computerised Systems Qualification and Validation processes according to the guidelines of WHO and FD
- Experience with the validation of cloud-based data platforms such as AWS, Azure, or Google Cloud Platform
- Knowledge of Pharma and Biotech Manufacturing (‘Make – Assess – Release processes’)
- Excellent problem-solving and analytical skills: Enable data pipeline monitoring , detect and recover from failures, monitor capacity and trigger auto-scaling if needed
- Strong communication and collaboration skills to work effectively with data engineers, data scientists, and business stakeholders
- Good communication skills
- Fluent in written and spoken english
Nice to Haves
- Pharma experience
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.