IT Infrastructure Quality Specialist

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Perfiles Diseño (IT)

Long-term contract


Competitive salary

  • Incorporación inmediata

Our client is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, it works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

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 the company's 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.

Your main tasks will be:
*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 (i.e. policies, procedures and protocols) used to establish or maintain compliance of computerized systems;
*Collaborate with the company's 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.

Risk Management
*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 the company's Computerized Systems Validation Framework (ECSVF) for IT Applications.

- 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.

*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

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