Senior Quality Assurance Associate

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider 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 has become one of the global leaders in its field. We cover all therapy areas including medical device. 

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.  

Under the supervision of line management and guidance of QA Officers and Managers, the Senior QA Associate is responsible for supporting the Quality Assurance (QA) team in all aspects of the design, implementation and management of internal and external audits and corresponding Quality Risk Management activities.

The Senior Quality Assurance Associate will assist in the hosting of audits.

Core Responsibilities

Participates in the scheduling, preparation, conduct and follow-up of internal and external (Client driven) audits and Regulatory Authority Inspections, including management of CAPA Plans and documentation.

As necessary, assists QA management with meeting logistics for, e.g., GQC Meetings, QA Group meetings, and others as directed by line manager.

Follows applicable processes and procedures for creating, filing, retrieving, storing, preserving, and protecting QA group records.

Tracks and manages periodic management reports that track and trend the quality health of GxP activities.

Develops and maintains Risk Assessments of vendors and internal systems/processes.

Develops responses to RFP/RFI and client questionnaires.

Supports the QA Group for assigned Process Improvement projects.

University degree in a scientific discipline, or equivalent industry experience

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.