Qa Tester

Digital55; Madrid; On-site; EUR 60,000 - 90,000; Full time

Job summary

IQVIA seeks a qualified QA Auditor to plan and conduct independent clinical (GCP) audits across Europe, ensuring compliance with regulations and SOPs. You will prepare reports, consult with project teams, and support management in regulatory adherence.

The role requires 30-50% travel, 5 years in pharma/QA, and strong communication and training skills. IQVIA offers opportunities across multiple European countries and a collaborative QA culture.

Qualifications

• Certified to conduct audits in Italy per 2011 health decree.
• 5 years in pharmaceutical/QA, with 3 in audits.
• Experience in clinical trial site audits and regulatory environments.

Responsibilities

• Plan, schedule, conduct, report and close audits across Europe.
• Evaluate findings and prepare reports for management and customers.
• Provide interpretation of regulations and guidelines to project teams.
• Review investigations, RCA, CAPA and EC plans and track closure.
• Lead QA initiatives and train new QA staff.

Skills

Auditing experience

Regulatory compliance

GCP knowledge

Interpersonal skills

Training capabilities

Education

QA auditor certification

Tools

Word processing (MS Word)

Spreadsheet (Excel)

Database apps

Job description

Madrid, Spain
Lisbon, Portugal
Budapest, Hungary
Belgrade, Serbia
Tallinn, Estonia
Zagreb, Croatia
Riga, Latvia
Prague, Czech Republic
Sofia, Bulgaria
Ljubljana - Dunajska, Slovenia
Bucuresti, Romania
Full time
R

Plan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of
regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.

Essential Functions

• Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions
• Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
• Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans
• Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits; and from Quality Issues, Inspections or during similar QA activities as assigned.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
• Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle
• Lead/collaborate/support in QA initiatives/projects for quality, process improvements
• Assist in training of new Quality Assurance staff
• May be required to manage Quality Issues
• May present educational programs and provide guidance to operational staff on compliance procedures
• May perform pre-inspection visits at sites, host audits/inspections; ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections, as assigned.

Qualifications

• The right candidate must be Certified to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 Nov 2011.
• Travel 30-50% mainly in Europe.
• 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits.
• Experienced in the conduct of clinical trial Investigator site audits.
• Experience in the conduct of clinical study report/data management clinical trial audits is preferred.
• Knowledge of word-processing, spreadsheet, and database applications.
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
• Knowledge of quality assurance processes and procedures.
• Strong interpersonal skills.
• Excellent problem solving, risk analysis and negotiation skills.
• Strong training capabilities.
• Effective organization, communication, and team orientation skills.
• Ability to initiate assigned tasks and to work independently.
• Ability to manage multiple projects.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent