Quality Assurance Officer

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: Nursing Pharmacy or BS/Masters degree in a scientific discipline 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 organisation
• Proactive and self-motivated

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  

We look forward to welcoming your application. 

Remote Work :

No

Employment Type :

Full-time