Offer summary

Qualifications:

University degree in a scientific discipline or equivalent industry experience., Strong understanding of Quality Assurance processes and regulatory requirements., Experience in conducting audits and managing CAPA plans., Ability to develop risk assessments and manage quality reports..

Key responsibilities:

Support the QA team in internal and external audits and Quality Risk Management activities.

Assist in scheduling and conducting audits and regulatory inspections.

Manage documentation and track quality health of GxP activities.

Participate in process improvement projects and provide training as needed.

Job description

Company Description

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.

Job Description

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.

· Undertakes other tasks assigned by QA management within individuals experience, training and capability as required.

· Trains in and complies with all relevant PrimeVigilance operating procedures as assigned.

Qualifications

University degree in a scientific discipline, or equivalent industry experience

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 on improving the lives of those around us.

We offer: