Poland, Senior QA Auditor - GCP Audits

168.1k - 312.1k PLN168 100 - 312 100 PLN/ rok./ rok.

SeniorOn-site·WarszawaFull-time

#477915·Dodano 4 dni temu·0

Źródło: IQVIA

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Tech Stack / Keywords

GCPRCACAPAeQMSSOPsEC

Podsumowanie oferty

Plan and conduct independent clinical GCP audits to assess compliance with regulations, guidelines, and operating procedures. Evaluate findings, prepare reports, and advise project teams and customers on compliance and corrective actions.

Wymagania

At least 5 years of experience in a GCP environment, including 3 years in Quality Assurance Site Audit.
Experience leading clinical trial Investigator site audits, with at least 7–10 audits per year.
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 work independently.
Ability to manage multiple projects.

Nice to have:

Certification to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 Nov 2011.

Obowiązki

Plan, schedule, conduct, report, and close audits in countries involved with IQVIA contracts.
Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
Advise project teams on regulations, guidelines, compliance status, policies, and procedures.
Advise customers and monitors on audit observations and corrective action plans.
Review and approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA), and Effectiveness Check (EC) plans, and track them through closure for quality events.
Evaluate policies and procedures for compliance and recommend continuous process improvements to management.
Maintain the electronic quality management system (eQMS) and support the audit lifecycle.
Lead, collaborate on, or support quality and process-improvement initiatives and projects.
Assist in training new Quality Assurance staff.
May manage Quality Issues.
May present educational programs and guide operational staff on compliance procedures.
May perform pre-inspection visits at sites, host audits and inspections, ensure the proper conduct of customer-initiated audits and mock regulatory inspections, and assist with regulatory facility inspections.

Benefity

Incentive plans, bonuses, and/or other forms of compensation may be offered, depending on the position.

Premie

Inne informacje

Travel 30–50%, mainly in Europe.

IQVIA

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