Descripción de la oferta
Quality GCP Auditor - Relocate to Madrid? Open to individuals already located in or willing to relocate to Madrid.
4 days a week onsite in Madrid.
General Responsibility
The Clinical Quality Auditor ensures the validation and compliance of eClinical systems, including Interactive Response Technology (IRT), Clinical Trial Management Systems (CTMS), Case Report Forms (CRF), Trial Master Files (TMF), Clinical Outcome Assessments (COA), and electronic Patient-Reported Outcomes (ePRO). This role involves cross-functional collaboration to uphold quality and regulatory compliance standards.
Additionally, the specialist will support the Global Quality Unit in developing, implementing, and maintaining the companies Clinical Quality System, ensuring compliance with GCP, GLP/GMP guidelines, EMA and FDA/CFR regulations, and other applicable standards.
Specific Responsibilities
Lead and manage validation activities for eClinical systems, ensuring regulatory compliance.
Establish, implement, and maintain the Global/Corporate Clinical Quality Assurance System.
Support the development and maintenance of Quality Assurance Systems across business units and affiliated units within the company group.
Develop and implement quality assurance processes and validation documentation, including plans, protocols, reports, and SOPs.
Conduct risk assessments and implement mitigation strategies for eClinical systems.
Lead and conduct qualification and vendor audits of CROs and third-party vendors for clinical trial activities.
Assist in external and internal audits, inspections, and vendor qualifications.
Support the selection and implementation of new Clinical systems and maintain a Global Clinical vendor/service provider database.
Oversee the follow-up on Corrective and Preventive Actions (CAPA) from audits and vendor qualifications.
Maintain the Corporate Auditing Management electronic system for tracking audits from initiation to closure.
Provide training and support on CSV processes and regulatory requirements.
Requirements & Personal Skills
Education: Bachelor's degree in Life Sciences (e.g., Chemistry, Pharmacy, Biology, Medicine), Computer Science, or a related field. A Master’s degree is a plus.
Languages: Fluent in English; additional languages are a plus.
Experience: 3-5 years of experience in computer system validation within the pharmaceutical or clinical research industry.
Knowledge: Strong understanding of regulatory requirements (FDA, EMA) and industry standards.
Travel: Willingness to travel up to 30% to clinical research units, biolabs, and company locations.
Email applicants:
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Quality Assurance, and Accounting/Auditing
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Chemical Manufacturing
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