Senior IT Quality Consultant- Engineering /regulatory / ICFR / GDPR / SCRUM
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Senior IT Quality Consultant
In this role, you are part of the IT Quality Assurance & Compliance unit in Diagnostics Informatics. Our ambition is to empower Diagnostics IT to deliver quality and compliance in an efficient way, right the first time.
Together with our Dia IT customers, we apply regulatory rules to modern technology like machine learning and new, agile development frameworks like SCRUM, DevOps, etc.
This position is an internal backfill. Please note the team is also recruiting for a permanent position. We are still opening the contract role to cover the longer internal process. The position will be supporting but the onboarding will be done from Basel/Kaiseraugst.
The perfect candidate is a senior profile with proven experience of quality assurance and compliance that can hit the ground running. We need someone with experience in regulatory compliance for Diagnostics and Medical Devices (please not experience in pharma will not match our need). This person should show experience as not only a validation lead (focusing on internal guidance) but also show knowledge of the regulatory background that led to the specific guidance.
This position is within Global IT and Business informatics, providing IT solutions for the business.
Due to the short timeframe of recruitment, (we need someone latest mid-April), please focus your search on geographically available candidates (Switzerland or cross borders)
Tasks & Responsibilities:
* Provide compliance advice and support to ensure that activities are conducted in accordance to internal procedures, international standards (GxP, ICFR, GAMP) and Health Authority regulations.
Provide IT Quality Assurance & Compliance support for DIA IT systems
Create and Review IT Quality Management Processes
* Create and review components of the DIA IT Quality Management System (SOPs, TOPs, Templates, Checklists, etc.) and define IT Compliance guardrails and enablers; Collaborate to create the future IT Governance Framework with IT processes and standards to keep these updated with the newest developments of external standards and best practices.
Ensure compliance to IT procedures and regulatory requirements
* Participation in execution, documentation and tracking of internal and external IT audits (Co-Auditor); Participation in the development of compliance specifications, based on guidelines, legal requirements and policies and their review; Oversight or execution of periodic reviews of DIA IT systems.Provide coaching & training on IT procedures and regulatory requirements
Nice to have: