CSV QA Lead (f/m/d)

CSV QA Lead (f/m/d) – WHO and FDA Guidelines / AWS, Azure, or Google Cloud Make – Assess – Release processes‘ / Analytical skills / Communication skills /English

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified CSV QA Lead.

Background:
Background: After careful consideration and analysis, Roche has decided to divest the manufacturing facility in Vacaville, California. The goal is to obtain a suitable buyer and safely divest it as an operating facility to a company that shares Roche’s core values and focuses on patients. In the limited period between legal transfer of the site to the buyer and the completion of the transfer of the current manufacturing portfolio to other locations respectively the discontinuation of its need, Vacaville will continue to operate as manufacturer of substances and service provider as an (external) supplier (CDMO) to the Roche supply chain network.

The perfect candidate: You will be assigned to a program called Dolphin, the Vacaville Site Divestment and responsible for ensuring that all systems planned to be handed-over to the new owner fulfill the Computerised Systems Validation (CSV) requirements for a Biotech Manufacturing Factory according to the guidelines of WHO and FDA. Roche PQS set of directives may be used as an additional, but legally not binding source of further information. As only a fraction of the currently used global systems will be localized and handed-over to the new owner, the CSV QA lead will monitor the E2E business process of ‚make – assess – release‘ and escalate potential validation gaps to senior project and site management. The CSV QA Lead will work in close cooperation with the Vacaville divestment Validation Lead, IT QA for Infrastructure, Vacaville local Quality representatives, IT System Owners, Business Process Owners as well as global and local members of the divestment project team.

Tasks & Responsibilities:
* Being responsible for ensuring the project is compliant with Roche 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 FDA
* 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

Reference Nr.: 923082SDA
Role: CSV QA Lead
Industrie: Pharma
Workplace: Basel / Kaiseraugst
Pensum: 100%
Start: 01.01.2024
Duration: 7++
Deadline: 14.12.2023

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.