Senior IT Quality Consultant (IT)
Senior IT Quality Consultant (IT)
Experis IT is Europe's leading IT recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across a number of professional sectors, with IT being at the heart of our operations.
For one of our pharmaceutical clients, we are looking for a Senior IT Quality Consultant
This is a 3 Months contracting position starting in April.
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.
* Proactively reviews and analyze working practices, as well as results of inspections, audits and metrics/key performance indicators and advises the management team of potential impact from a compliance / process perspective.
Provide IT Quality Assurance & Compliance support for DIA IT systems
* Oversee quality and compliance related activities, such as validation, qualification, system risk assessments, etc., for the assigned DIA IT systems; Provide consultancy to stakeholders regarding IT compliance, processes and standards considering the dynamic agile IT environment; Ongoing support of ITSM processes, e.g. Change- and Configuration management; Consulting of system support & project teams concerning IT Quality Assurance and Compliance topics (such as CSV, GDPR, ICFR, etc.).
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
* General coaching and training for governance topics like: (Built-In-) IT compliance, IT quality, data privacy and integrity; Contribution to the continuous improvement in the IT regarding the regulatory environment.
* Min 5 years of experience in a similar role with understanding of regulatory background leading to internal guidance
* Proven experience in regulatory compliance (CSV, Data Integrity, ICFR, GDPR, etc)
* Experience in Diagnostics/Medical Devices
* Experience with Agile frameworks
* Proven adaption of regulatory compliance rules to new technologies (e.g. Cloud computing, RPA, machine learning) in a leading position
* Proven working experience in IT Quality Assurance functions (Validation Lead, Quality management, Auditing) in the medical device or pharmaceutical industry.
* Passionate about supporting and consulting IT delivery teams to strive for compliance in a collaborative way
* Eager to manage, improve, monitor and automate IT quality processes as a basis for data driven decision making (ITIL, COBIT certification are welcome)
* Experience in outsourcing of IT services (Offshoring, Cloud-Migration, test center, etc.)
Nice to have:
* Proven working experience in CSV in agile frameworks (SCRUM, SAFe)
* Experience in SOC reporting
* CISA certification
* Lean Six Sigma certification
* German speaking skills
End date: 30.06.2021
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