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Quality Management Officer (QEs & CAPAs), Warsaw

Client:

Location: Warsaw, Poland

Job Category: Other

EU work permit required: Yes

Job Reference: 612195a65abb

Job Views: 4

Posted: 23.01.2025

Expiry Date: 09.03.2025

Job Description:

The Quality Management Officer is responsible for ensuring that Quality Events (QEs) and Corrective and Preventative Actions (CAPAs) are completed in an accurate and timely fashion and are managed in compliance with global regulations, legislation, and PrimeVigilance requirements.

• Lead the administration, tracking, and management of QEs and CAPAs at PrimeVigilance.
• Support Subject Matter Experts to conduct root cause analysis of QEs and CAPAs.
• Lead QEs and CAPAs through the workflow.
• Provide support to operations and act as subject matter expert on the process of managing QEs and CAPAs.
• May participate in audits and inspections to act as a QE and CAPA subject matter expert.
• May support the Quality Manager, QE, and CAPA team for periodic trending of deviations data across the company.
• Preparing metrics on procedures and trainings for internal Quality and Compliance reporting.

Qualifications

Education:

• University degree in Biomedical sciences, Natural sciences, or Health Sciences is required: Nursing, Pharmacy, or BS/Master degree in a scientific discipline, or equivalent advanced degree with experience.

Experience:

• Previous Pharmacovigilance experience is desirable.
• Prior experience in a Quality and/or Compliance role is required.
• Prior experience in Medical Information, Medical Devices or IT is desirable but not required.

Special Skills:

• Experience of using an electronic Quality Management System desirable but not required.

Language Skills:

• Fluent in English (additional language is a plus).

PC Skills:

• MS Office, particularly advanced skills in Excel and Word.

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders, and ages can contribute and grow.

To succeed we must work together with a human-first approach. Why? Because our people are our greatest strength leading to our continued success in improving the lives of those around us.

We offer:

• Training and career development opportunities internally.
• Strong emphasis on personal and professional growth.
• Friendly, supportive working environment.
• Opportunity to work with colleagues based all over the world, with English as the company language.

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

We look forward to welcoming your application.

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