For our client, a well-known pharmaceutical company in Basel, we are looking for a CSQA Compliance Lead (m/f/d)
Background
The perfect candidate has experience in either IT Quality or Business QA as a CSV expert. This person has experience working with both Agile and Waterfall project delivery methodologies and understands ITIL, as well as Quality Change and Problem Management. This person is familiar working as a QA Owner for Change, CAPA, and Deviations.
General Information
General Information
Start date: asap
latest Start Date: 01.10.25
Planned duration: 12 months
Extension (in case of limitation): possible
Workplace: Basel
Workload: 80-100%
Home Office: up to 2 days a week
Tasks and Responsibilities
Tasks and Responsibilities
- Review CSV deliverables to ensure compliance with GxP and internal standards
- Evaluate IT Change and Problem Tickets from a QA perspective
- Support general QA activities like audits, SOP reviews, and inspections
- Perform risk assessments for IT systems and planned changes
- Review test plans and reports for completeness, traceability, and compliance
- Assess and manage Change Requests throughout the full change lifecycle
Must Haves
- BA/BS in Computer Science or equivalent experience in Industry (5-10 years)
- 5 Years experience in CSV
- IT skills required: Google Suite, Microfocus ALM, Veeva QMS is a +, Service Now
- Language skills: English Fluent and German would be a plus
- Soft skills required: calm, good negotiator, understanding of complex problem
- solving,understanding on GMP a requirements
Contact
Jan Schmitz-Elsen
Talent Acquisition Consultant
+41 61 500 01 74
jan.schmitz@datalynx.ch