Quality Analytics and Validation Specialist

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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.

This is a remote position.

Summary:

The Lead Specialist of QA&V is responsible for deploying and maintaining the eProgesa Blood Establishment Computerized System (BECS) through the design and execution, of all aspects of software test activities including user requirement reviews, test methodology design, integration testing, regression testing and software QA&V activities. The Lead Specialist, QA&V will be responsible for developing and management of project plans ensuring the goals and objectives of each QA&V Department project are achieved on time and within budget. This individual will participate in the development and execution of user requirements as well as design and execute verification and validation test procedures. 

Responsibilities:

• Design and execute validation projects of the QA&V Department ensuring the GBS Department meets its corporate goals.
• Assist with the development and maintenance of the GBS validation strategy, policies, and procedures.
• Develop and participate in the execution of software, hardware, and process validation protocols (per GBS business and compliance goals).
• Coordinate internal and external validation resources, monitor and report progress of each QA&V project, protocol, and report.
• Execute QA&V procedures and protocols in compliance with GBS requirements, user and manufacturer’s specifications and applicable government regulations.
• Train external and internal (GBS) personnel on basic QA&V principles, procedures, and protocols.
• Assist in the definition and implementation of continuous improvement processes within the QA&V department.
• Perform the collection, collation, validation and reporting of KPIs as captured from the BECS system.
• Other duties as assigned.
• Travel up to 25%.

PERSONAL ATTRIBUTES:

• The ability and desire to work in a fast-paced team environment, routinely interfacing with Operational, IT, QA, RA, and vendor personnel.
• Demonstrated ability to lead multiple projects simultaneously, set priorities, identify, and addresses unexpected outcomes, meet deadlines and project budget guidelines.
• The ability to lead cross-functional project teams …