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.

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 QA Associate will support the QA team to ensure internal/external audits are developed, managed, maintained, and delivered in line with PrimeVigilance procedures.

The QA Associate will conduct all activities described, including but not limited to:

Audits/Inspections

• Schedules/hosts/supports audits (routine, due diligence, qualification) and inspections of PrimeVigilance performed by clients/third parties and regulatory authorities as agreed with the Senior QA Officer, Quality Audits Manager and/or Director, QA.
• Supports PrimeVigilance functional teams pre-, during and post-audit/inspection by clients or by internal QA function.
• Assists in client specific requests for audit scheduling.
• Assists in maintenance of trackers involved for audit related tasks and the maintenance of the SharePoint.
• Supports the oversight, maintenance, scheduling of audits and inspections of PrimeVigilance performed by clients/third parties and regulatory authorities.

CAPA Support Activities

• Supports in tracking of the vendor audit CAPAs.
• Support in the facilitation and review of vendor CAPA responses
• Input into the global audit CAPA tracker

Internal Audits

• Ensures documents and trackers from internal system and/or vendor audits initiated by PrimeVigilance are kept up to date.
• Assists in the development and maintenance of the internal risk assessments.
• Conducts other ad-hoc activities as requested by Quality Audits Manager and/or Director, Quality.

Specified Additional Responsibilities

• The Senior QA Associate will also support the Global Quality Function as needed.
• Other QA support as needed.

University degree in a scientific discipline, or equivalent industry experience

Essential

• Previous experience in the pharmaceutical and/or regulated industry in a quality setting – preferably in Pharmaceuticals or Healthcare.
• Understanding of the principles of Quality Assurance.
• Excellent communication and facilitation skills within a global organization.
• Excellent approach to workload management and ability to deliver results in tight timelines.
• Flexible approach to work and positive response to process change where necessary.
• Good attention to detail.
• Proactive and self-motivated.
• Good organization skills and ability to multitask.

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.