Do you have a compliance mindset and a strong background in IT and science? Do you enjoy collaborating with international teams?
We are looking for a IT Infrastructure Quality Specialist to join a challenging and unique large-scale Transformation Program with high impact and visibility.
The IT Infrastructure Quality Specialist will review, revise and develop documentation to establish and maintain GxP compliance of its IT systems and applications.
Specifically, this responsibility includes collaborating with Eurofins business partners and technical leaders to define IT system requirements;
drafting and reviewing SOPs and policies to ensure compliance with relevant rules and regulations; drafting and reviewing IQ / OQ forms, qualification plans and validation plans for IT systems;
and identifying and implementing continuous improvement initiatives.
This role requires experience in GAMP Infrastructure Control and Compliance and GxP guidelines and regulations.
Conceive, Own, Ensure the implementation of the IT Infra Qualification Framework
Accountable for the development and implementation of Quality Programs in accordance with GxP practices;
Establish a Qualification Master Plan by collaborating with SMEs from IT Infrastructure, IT Security, Project Management and Quality Assurance (business);
Ensure that relevant IT Team members are trained on IT Qualification / Validation, as per GxP / GAMP fundamentals;
Gathering requirements, compiling project documentation, facilitating workshops to agree on scope and schedules; developing Project Plans
Support the IT Infrastructure teams to create, revise and endorse the documentation set policies, procedures and protocols) used to establish or maintain compliance of computerized systems;
Collaborate with Eurofins businesses and IT infrastructure teams to define technical and business requirements associated with the lifecycle of IT systems;
Translate requirements, concepts and ideas into detailed, tangible documents, diagrams, charts, and other written or visual media;
Identify and implement continuous improvement initiatives.
Drive and Govern IT Infrastructure Qualification efforts
Ensure IT Infrastructure Qualifications and Maintenance in agreement with GAMP Infrastructure Control and Compliance ;
Support the IT Infrastructure teams to carry out the Qualification / Testing Activities and to generate reports;
Coach / Oversee the IT Infrastructure teams to maintain IT Infrastructure (and its documentation) in Qualified state once in operation;
Assist User Zones with Qualification Documentation required for regulatory / customer Audits;
Support / Audit IT Infrastructure Support Teams to ensure compliance of their operations to GxP and other applicable regulatory standards.
Create / Collaborate on IT Risk Management Process / documents in alignment with industry standards;
Work with Global IT Risk and Compliance Team for smooth implementation of relevant process within Zones;
Support with Software Validation efforts
Help Zone IT Solution Teams to ensure compliance of their IT Services (Solutions) with GxP and other applicable regulatory standards;
Provide Support / Training for implementing Eurofins Computerized Systems Validation Framework (ECSVF) for IT Applications;
Are you our kind of extraordinary?
You will have a Scientific or Technical Degree and 3 to 7 years in a similar position and a proven track record in application of GxP in service-oriented matrix organisation.
You have experience in understanding business requirements and translating them into something understood by the lay person.
We are looking for team players fluent in English , with excellent communication skills and system thinking (big picture thinkers), who would be able to work under minimal supervision.
The role can also be based in :
What can we offer you?
A multicultural, friendly and collaborative work environment in a fast-growing international company
Opportunities for growth and take that next step in your professional career and self-development
Long-term engagement and career development