CSV QA Lead
CSV QA Lead
Jobdescription
Are you an experienced CSV QA lead? Do you have profound experience in computerized Systems Qualification and Validation processes according to the guidelines of WHO and FD?
Then please read the job description below.
Tasks & Responsibilities:
Your profile:
Looking forward to your application.
Are you an experienced CSV QA lead? Do you have profound experience in computerized Systems Qualification and Validation processes according to the guidelines of WHO and FD?
Then please read the job description below.
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
Your profile:
- 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
Looking forward to your application.
Moutusi Chattopadhyay
Adresse
Randstad (Schweiz) AG
À propos de l'entreprise
3,7 (125 évaluations)
