Quality Assurance Officer

**Company Description**
We are PrimeVigilance (part of Ergomed PLC), 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.
**Job Description** Role and Responsibilities**
- The Quality Officer will support all audit activities within PrimeVigilance and will work with the Auditing team and Quality team s to ensure audits are delivered in line with PrimeVigilance and procedures and global regulations.

The Quality Officer will perform all activities described, including but not limited to:

- Audit Support:

- Supports PrimeVigilance functional teams during the pre-audit, audit, and post-audit stages for audits by clients or by PrimeVigilance internal QA function
- Hosts onsite and remote audits
- Provides support for regulatory inspections of clients
- Assists in scheduling client requests for audits/inspection support
- Administrative support
- Supports Quality in the tracking of audit status and deliverables
- Metrics and Key Performance Indicators
- Supports Quality in the compilation and reporting of metrics and KPIs
- Collects and collates data from systems and sources
- Authors reports and summaries
- CAPA Support Activities
- Supports Quality in the tracking of Deviations and CAPAs
- Facilitates CAPA response and resolution
- Inputs data into the global audit CAPA tracker
- Other Supportive Responsibilities:

- Supports Controlled Document preparation by reviewing draft documents, e.g., SOPs, OGs
- Supports the PrimeVigilance Senior Leadership team as needed.
- Supports other Quality activities as needed.

**Qualifications**
- **_ University degree in Biomedical sciences, Natural sciences or Health Sciences is required: Pharmacy or BS/Master’s degree in a scientific discipline, Nursing, or equivalent advanced degree with pharmaceutical industry experience. Or equivalent pharmaceutical industry experience._**:

- Previous experience in the pharmaceutical and/or regulated industry in a quality setting - preferably in Pharmaceuticals or Healthcare
- Thorough understanding of the principles of Quality Assurance
- Knowledge of national regulations and guidance related to Pharmacovigilance and Medical Information
- Experience of participating in audits and inspections
- Excellent communication and facilitation skills within a global organization
- Proactive and self-motivated
- Advanced knowledge of English

**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**:

- 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