IQVIA

Sr. Quality Auditor, CAPA Centre of Excellence

168.1k - 312.1k PLN168 100 - 312 100 PLN/ rok./ rok.UoPUmowa o pracę (brutto)

SeniorOn-site·WarszawaFull-time·Umowa o pracę

#454493·Dodano 16 dni temu·0

Źródło: IQVIA

Aplikuj teraz

Tech Stack / Keywords

CAPA ManagementGCPRoot Cause AnalysisClinical TrialsAuditInspectionMicrosoft OfficeeQMS

Firma i stanowisko

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

Wymagania

Bachelor's Degree.
Extensive knowledge of CAPA Management, GCP guidelines, and relevant clinical trial regulations.
Prior experience in audit and inspection management/support.
Skills in root cause analysis and quality investigations.
Ability to independently manage complex quality issues.
Experience reviewing and driving CAPAs to closure.
7 years of Quality Assurance experience in pharmaceutical or related areas focusing on GCP in Clinical Trials.
Background in science, healthcare, or related discipline with detailed understanding of clinical trial processes.
Strong leadership and organizational skills.
Excellent problem solving and root cause analysis skills.
Excellent training and mentoring capabilities.
Ability to manage multiple projects independently in a fast-paced environment.
Effective communication skills in one-to-one and group settings.
Proficient in Microsoft Office applications (Word, Excel).

Obowiązki

Lead and mentor CAPA management team members to ensure compliance with regulations and guidelines.
Lead and support CAPA activities for complex quality issues and sponsor audits and inspections.
Collaborate with cross-functional stakeholders to identify process gaps and improvements.
Ensure proper reporting and documentation of CAPAs in the electronic quality management system (eQMS).
Promote continuous process improvement by identifying risks and optimizing CAPA processes.
Facilitate effective communication among department stakeholders and staff.
Develop and provide training and guidance on Root Cause Analysis (RCA), CAPA management, and compliance.
Develop and improve procedures, templates, and work instructions to streamline processes.
Advise Quality Assurance management on system audit needs.
Support external and internal audits and inspections, ensuring inspection readiness.

Benefity

Incentive plans, bonuses, and other forms of compensation.
A range of health and welfare benefits.

Inne informacje

IQVIA maintains a zero tolerance policy for candidate fraud. False statements or omissions will result in disqualification or termination in accordance with applicable law.

IQVIA

32 aktywne oferty

Zobacz wszystkie oferty

Aplikuj teraz