R&D Quality Assurance Audit Specialist"

Grifols-posted 7 months ago

Mid Level

Chemical Manufacturing

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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 are seeking a dedicated professional to join our SIO Plasma R D QA team. In this role, you will oversee quality tasks and audits assigned to the group, ensuring compliance with GxP regulations, Grifols' Global Quality System, and specifically the R D Quality System.

Supervision of Documentation Generated by Pre-Clinical SIO Groups
Review of primary data related to studies, following internal procedures and applicable regulations/guidelines, if necessary (GCLP, GMP, GLP)
Review and approval of study protocols and reports, following internal procedures and applicable regulations/guidelines, if necessary (GCLP, GLP)
Review and approval of procedures, following internal procedures and applicable regulations/guidelines, if necessary (GCLP, GLP)
Participation in the planning of the R D QA Annual Audit Plan to define internal audits for various SIO Pre-Clinical groups, based on procedures, risk analysis, and new studies
Conducting scheduled internal audits for SIO Pre-Clinical groups, which may include facilities or studies
Conducting audits requested by other groups external to SIO Pre-Clinical, within the expertise area of R D QA
Conducting the qualification and re-qualification process for vendors used by SIO Pre-Clinical groups
Conducting qualification and re-qualification audits for vendors, as deemed necessary
Conducting qualification and re-qualification audits requested by other Grifols Quality groups, within the expertise area of R D QA
Review and approval of deviations from groups generated under the supervision of R D QA
Management, review, and approval of CAPAs from groups generated under the supervision of R D QA
Monitoring KPIs related to Quality Management of groups under the supervision of R D QA
Compilation and drafting of the R D Quality Annual Report
Participation in adapting the R D Quality System to new situations that may arise
Drafting and reviewing procedures
Acting as a Quality expert within multidisciplinary teams for new Grifols projects
Managing and collaborating with IT in the technical maintenance of the R D Quality System
Communication with different groups located worldwide

Life Sciences Degree
A minimum of 2 years, preferably 5, in a similar role or relevant experience in Quality
Strong integrity and commitment to quality and compliance
Ability to understand pharma-related regulations and proficiency with computers
Ability to work flexible schedules to meet business needs
Demonstrating good organizational skills and attention to detail
High capacity for teamwork
Strong interpersonal communication, organizational, and problem-solving skills
Analytical, evaluative, and conflict resolution skills

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R&D Quality Assurance Audit Specialist"

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