Quality Specialist, Deviations & CAPAs

The Quality Specialist is responsible for ensuring that Deviations (Devs) and Corrective and Preventative Actions (CAPAs) are completed in accurate and timely fashion and are managed in compliance with global regulations, legislation and company requirements.

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

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 (GVP) experience is desirable
• Previous Clinical (GCP) experience is beneficial
• 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.

Why PrimeVigilance 

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 on 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

Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.