Software QA Engineer

Discover International; Madrid; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An innovative firm is seeking a Quality GCP Auditor to ensure compliance and validation of eClinical systems. This role involves leading validation activities, developing quality assurance processes, and collaborating across departments to uphold regulatory standards. The ideal candidate will have a strong background in Life Sciences, with 3-5 years of experience in the pharmaceutical industry. Join a dynamic team dedicated to maintaining high-quality standards and compliance in clinical research. If you're passionate about quality assurance and regulatory compliance, this opportunity is perfect for you.

Formación

• 3-5 years of experience in computer system validation in the pharmaceutical industry.
• Strong understanding of regulatory requirements (FDA, EMA).

Responsabilidades

• Lead validation activities for eClinical systems ensuring compliance.
• Develop and implement quality assurance processes and validation documentation.

Conocimientos

Computer System Validation

Regulatory Compliance

Risk Assessment

Quality Assurance Processes

Cross-Functional Collaboration

Educación

Bachelor's degree in Life Sciences

Master’s degree in a related field

Herramientas

eClinical Systems

Clinical Trial Management Systems (CTMS)

Interactive Response Technology (IRT)

Descripción del empleo

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.

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