Operational Quality Officer

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Manage deviations and CAPAs within the department, working with Subject Matter Experts (SMEs) • Support SMEs in conducting root cause analysis for deviations and CAPAs • Ensure timely completion of actions • Act as point of contact for audit and inspection CAPA preparation and action delivery • Drive audit and inspection readiness within the department • Review data to drive continuous quality improvement and excellence • Deliver proactive department-specific audit and inspection readiness training • Arrange targeted interview practice with department SMEs • Contribute to departmental quality training material • Ensure delivery of data required for quality and compliance metrics • Work with quality counterparts and the head of department to improve departmental quality

🎯 Requirements

• University degree in Biomedical sciences, or relevant experience • 2–3 years of work experience in pharmacovigilance • At least 2 years of ICSR experience is necessary • Prior experience in a Quality and/or Compliance role is required • Problem-solving skills and ability to approach issues independently using own initiative • Experience using an electronic Quality Management System is desirable • Excellent written and verbal English communication skills • Organization skills, including attention to detail and multitasking • Delegation skills • Planning and time management skills • Technical skills • Team working skills • Advanced literacy in MS Office

🏖️ Benefits

• Remote work option • Flexible, collaborative and supportive work environment • Growth opportunities • Opportunity to work with global teams • Passionate and collaborative team of experts • Inclusive workplace where every voice counts