QA Auditor 2 clinical research home-based

QUK IQVIA; Barcelona; A distancia; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Quality Assurance professional to enhance compliance and quality processes. In this pivotal role, you will support audit activities, manage quality issues, and provide expert consultation on regulations and guidelines. You will lead initiatives aimed at continuous improvement and ensure adherence to quality standards. This position offers a unique opportunity to contribute to impactful projects within the life sciences sector, promoting a culture of excellence and compliance. If you thrive in a dynamic environment and are passionate about quality assurance, this is the role for you.

Formación

• 3+ years of experience in pharmaceutical or related areas.
• Knowledge of GXP regulations and QA auditing techniques.

Responsabilidades

• Support audit response activities and evaluate audit findings.
• Manage quality issues and approve investigations and CAPA plans.

Conocimientos

GXP Regulations

Quality Assurance

Problem-Solving

Communication Skills

Organizational Skills

Educación

Bachelor's Degree

Herramientas

Word Processing Software

Spreadsheet Applications

Database Applications

Descripción del empleo

Support quality issues management, Customer Audit / Regulatory Inspections report response management, Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plan review, approval, and closure. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance with regulations, guidelines, and corporate policies. Lead/support QA initiatives/projects for quality process improvements.

Essential Functions

1. Support audit response activities across countries involved with IQVIA contracts, assessing compliance with applicable regulations, guidelines, customer requirements, Standard Operating Procedures (SOPs), and project-specific instructions.
2. Evaluate audit findings and prepare/distribute responses to operations staff and management.
3. Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, policies, and procedures.
4. Assist staff in interpretation of audit observations.
5. Manage Quality Issues
6. Review and approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA), and Effectiveness Check (EC) plans. Track until closure for quality events arising from Quality Issues, Audits, Inspections, or similar QA activities.
7. Present educational programs and guide operational staff on compliance procedures.
8. Provide quality assurance consultancy activities and projects for clients within budget and timelines.
9. Evaluate policies and procedures for compliance and recommend continuous process improvements.
10. Assist in training new Quality Assurance staff.
11. Support QA initiatives/projects for quality process improvements.
12. Manage / oversee quality events in eQMS
13. Maintain the electronic quality management system (eQMS) and support the audit lifecycle.

Qualifications

1. Bachelor's Degree preferred.
2. At least 3 years of experience in pharmaceutical, technical, or related areas including GXP and/or Quality Assurance. Equivalent education, training, and experience considered.
3. Knowledge of word processing, spreadsheets, and database applications.
4. Considerable knowledge of GXP regulations and QA auditing techniques.
5. Strong interpersonal, problem-solving, organizational, communication, and team skills.
6. Ability to initiate tasks and work independently.
7. Ability to manage multiple projects.
8. Ability to establish and maintain effective relationships with coworkers, managers, and clients.

Additional info: LIremote

About IQVIA

IQVIA is a leading global provider of analytics, technology solutions, and clinical research services to the life sciences industry. We aim to push the boundaries of human and data science to make a significant impact, helping our customers create a healthier world. Learn more at our website.

Key Skills

CSS, Cloud Computing, Health Education, Actuary, Building Electrician

Employment Details

Type: Full-Time

Experience: Years

Vacancy: 1