\\n Our customer is a fast-growing international pharma company in the region Basel. Own innovative pharmaceutical products are developed in Basel and marketed in diverse countries, mainly Europe. Also numberous collaborations with pharmaceuticals research centres and universities are part of the innovation strategy.
To strengthen the team, we are looking for an experienced CSV engineer
Your responsibility:
Responsible for QA related tasks in relation to data integrity and electronic records management
Ensure Software and IT compliance e.g. : computerized system validation, supplier
(re)qualification for computerized systems and services
Responsible for QA related tasks for IT Changes and for Serialisation/TES
Review and approval of computerized system validation in general
Represent QA in CSV-related projects
ERP Key User and Core Team Member (incl. Master Data Management)
Coordination of quality relevant relations deviations, CAPA, changes
Manage and maintain the revision/compilation of quality documents
Review of batch documentation / perform shipment release
Your profile:
BSc. in a life science-related discipline
3-5 years in validation with focus on CSV
GMP knowledge 21 CFR Part 11 and EU GMP Guide Annex 11 and GAMP5
QA Compliance data integrity in Pharma, ERP systems
Fluency in English and German (in written and spoken)
Your are a flexible and structured team player with the ability to work in a fast-paced, rapidly changing environment. You have an efficient problem-solving approach as well as the ability to work under pressure and prioritize tasks.
Interested? We are looking forward to get in touch with you.\\n \\n \\n \\n \\n \\n
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