IT Validation Technician

Grifols
Barcelona, Spain
21 days ago
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Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience required
3 years minimum
Working hours
Regular working hours
Languages
English
Job source

Tech stack

Data Integrity Information Technology GXP

Job description

Management, Planning, and Strategic Alignment - Builds effective and trusting working relationships with all business and IT partners in areas of responsibility and collaboration. - Continuously improves knowledge of business processes, industry trends, and IT systems to better communicate IT capabilities and support IT solutions development. - Project Delivery and Management - Proactively identifies project risks and issues, helps determine necessary escalation, mitigation, and resolution steps. - Regularly communicates deliverables status, concerns, and issues to direct Manager, the Project Manager, and the project team. - Participates in estimating project cost and time requirements, assessing capabilities and support/resource requirements in area of responsibility. - Creates, reviews, updates, and may approve CSV documentation for changes and projects as assigned in accordance with IT Methodology: Validation Plans, Risk Analysis, Validation Test Designs and Reports. - Assures the compliance of the GxP relevant IT systems with the regulatory and data integrity requirements. - IT Operational Support - Ensures IT quality and regulatory compliance through adherence to quality control standards in all activities. - Contributes to the development, documentation, and evolution of IT policies, procedures, and tools to align with business and IT strategies and ensure sustainability of services - Regularly communicates individual task status, open issues, and challenges to impacted stakeholders and/or direct manager. - Knowledge Sharing and Consulting - Participates in the education of partners in industry and IT best practices in areas of responsibility and expertise. - Mentors peers and junior level staff with both challenging and routine assignments by sharing knowledge and experience. - Shares developing expertise of industry and IT best practices with peers and business partners. - May participate in the development of ongoing training

Requirements

for IT staff in specific areas of knowledge. - Provides support in the event of internal and external audits of validated systems, preparing supporting documentation as required. - Participates in the continuous enhancement of systems, technologies, methodologies, and services to improve IT effectiveness and system performance. Who You Are To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions). - Bachelor’s degree in Life Sciences (Biology, Pharmacy, Biotechnology, Chemical or a related discipline). - Minimum of 3 years of proven experience working within a regulated pharmaceutical environment, including GxP compliance. - Solid understanding of project management methodologies, tools, and best practices. - Knowledge of regulatory requirements and GxP standards applicable to computerized systems. - Experience supporting regulatory inspections and audit responses. - Strong attention to detail with the ability to manage multiple priorities simultaneously. - Ability to work both independently and collaboratively in cross-functional and international teams. - Excellent organizational, communication, and problem-solving skills. - Advanced in English, with the ability to work effectively in an international environment. What We Offer It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment. Information about Grifols is available at www.grifols.com. If you are interested in joining our company and you have what it takes for such

About the company

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding. Mission The IT Validation Technician actively contributes to the execution of the defined validation methodologies which comply with company standards and regulatory requirements. This role also oversees teams and validation resources engaged in validation activities. What Your Responsibilities Will Be - Relationship

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