As the premier supplier to our client, one of the most established pharmaceutical companies worldwide, Swisslinx are looking for a Senior IT Quality Assurance Consultant to work on a 3-month contract.
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. 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.
In this role you will be responsible for the following tasks:
- Provide compliance advice and support to ensure that activities are conducted in accordance to internal Roche 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
- Oversee quality and compliance related activities, such as validation, qualification, system risk assessments, etc; 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 components of the 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
In order to be considered for this role you must have the following skills:
- 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 leading position
- Proven working experience in IT Quality Assurance functions (Validation Lead, Quality management, Auditing) in the medical device or pharmaceutical industry.
If you possess the above attributes, available to start a new position immediately and looking for a new challenge in an international environment, we look forward to receiving your application!