Quality Management Officer QEs CAPAs

The Quality Management Officer is responsible for ensuring that Quality Events (QEs) and Corrective and Preventative Actions (CAPAs) are completed in 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 or QEs and CAPAs
• Lead QEs and CAPAs through the workflow
• Provide support to operations and act as subject matter expert on 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 humancentric 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  

We look forward to welcoming your application. 

Remote Work :

No

Employment Type :

Fulltime