PV Auditor
€5,300 - €7,600 per month
Key Skills
Job Description
We are looking for a detail-oriented and experienced QA/PV Auditor to join our Quality and Pharmacovigilance team. In this role, you will be responsible for conducting audits, ensuring compliance with GMP and PV regulations, and supporting continuous quality improvement initiatives across the organization. Key Responsibilities Plan, prepare, conduct, and report GMP and Pharmacovigilance (PV) audits Assess compliance with applicable regulations, internal procedures, and quality standards Identify risks, non-conformities, and improvement opportunities Follow up on CAPAs (Corrective and Preventive Actions) Support inspection readiness activities Collaborate with internal stakeholders and external partners Maintain accurate audit documentation and records Contribute to the development and improvement of quality systems and processes Provide guidance and training related to QA/PV compliance when required Profile Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Quality Management, or related field Proven experience in GMP and/or Pharmacovigilance auditing Strong knowledge of applicable GxP regulations and quality systems Excellent analytical and communication skills Ability to work independently and manage multiple priorities Strong attention to detail and problem-solving mindset Fluent in English; additional languages are considered an asset What We Offer A fulltime employment of 40 hours per week Salary range €5300 - €7600 A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly A personal training budget of €2,100 every three years to foster professional growth and development. Flexible working hours after deliberation Your own place in a close-knit and expert team with an employer that stimulates growth and personal development Contribution to travel expenses from the first kilometer Excellent accessibility by public transport and private parking available. Sound pension provision.
Core Responsibilities
Plan, conduct, and report GMP and pharmacovigilance audits, assessing compliance and identifying risks, non-conformities, and improvement opportunities. Follow up on corrective and preventive actions, support inspection readiness, maintain audit records, and contribute to quality systems and compliance training.
Requirements
A bachelor's or master's degree in life sciences, pharmacy, quality management, or a related field is required, along with proven experience in GMP and/or pharmacovigilance auditing. Candidates should have strong knowledge of GxP regulations and quality systems, excellent analytical and communication skills, attention to detail, and the ability to work independently and manage priorities; fluency in English is required.
Benefits
- Holiday Allowance
- Year-End Bonus
- Personal Training Budget
- Flexible Working Hours
- Travel Expense Contribution
- Public Transport Accessibility
- Private Parking
- Pension Plan
- Professional Development
About Prothya Biosolutions
Industry: Pharmaceutical Manufacturing
Company size: 1,001-5,000 employees
Prothya Biosolutions was formed in 2021, when Plasma Industries Belgium (PIBe), with roots in the Belgian Red Cross, integrated with Sanquin Plasma Products (SPP), a former subsidiary of the Sanquin Blood Supply Foundation (Stichting Sanquin Bloedvoorziening). Prothya Biosolutions offers over 60 years of experience in the collection of blood plasma and production of plasma-derived medicinal products, and a long legacy of collaboration, innovation, and delivery of science-based solutions. Thanks to our diverse background, we recognize the unique value of plasma-derived medicinal products for people and society, and reflect this in our ongoing transformation into a results-driven and global organization. Stable plasma derivatives such as clotting factors, immunoglobulins and albumin solutions are produced with the fractions isolated by Plasma Industries. At Prothya, we believe the best medicines are already in your body. The human plasma proteome holds the promise of a revolution in disease diagnosis and therapeutic treatment. We will continue to play a leading role in discovering how the abundance and structure of proteins can change the way we treat human diseases. Prothya Biosolutions processes around 3 million liters of plasma each year for several international partners. This change in focus entailed a change in corporate culture. Prothya has a clear vision we call DRIVE, embodying the core values on which our organization is founded. Do you want to play an active role in improving the health of millions of patients? Would you like to be our partner or future colleague at the forefront of new developments in the Protein Therapy Development, Processing and Manufacturing? Then you are welcome at Prothya Biosolutions!