Quality Management Associate (Quality Events & CAPAs)

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. 

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical devices. 

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. 

Come and join us in this exciting journey to make a positive impact in patient’s lives.  

The Quality Management Associate, QEs and CAPA and is supporting administration, tracking and ensuring that Quality Events (QEs) and Corrective and Preventative Actions (CAPAs) are completed in accurate and timely manner and are managed in compliance with global regulations, legislation and PrimeVigilance requirements.

Role and Responsibilities

• Support PrimeVigilance Quality Team and Quality Manager, QEs and CAPA in recording and tracking deviations, non- conformities, issues - and CAPA plans.
• Support the Quality Manager, QE and CAPA team for gathering information of deviations data across the company
• Assisting Quality Manager, QE and CAPA Team in developing and managing project-specific documentation, deviation and CAPAs trackers and in managing relevant project- specific training
• Supporting and assisting Subject Matter Experts to conduct root cause analysis or QEs and CAPAs
• Assist QE and CAPA, Quality manager in audits and inspections to by providing and gathering information of deviations, documentation on relevant projects.
• Support administrating and tracking deviations and reviewing CAPAs process

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 desirable.
• 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.

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  

We look forward to welcoming your application.