PV Auditor

Prothya Biosolutions; Amsterdam; On-site; EUR 60,000 - 85,000; Full time

Benefits offered by this job

Travel expense support

Training budget €2,100 every 3 years

Holiday allowance 16.66% of gross pay

Job summary

Prothya Biosolutions is seeking a QA/PV Auditor to join the Quality and Pharmacovigilance team in Amsterdam. You will conduct GMP and PV audits, ensure regulatory compliance, and drive continuous quality improvements across the organization.

The role requires a life sciences or quality management degree, proven GMP/PV audit experience, strong GxP knowledge, and excellent analytical and communication skills. English fluency is essential; other languages are an asset.

Qualifications

• 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.
• Fluent in English; additional languages are assets.

Responsibilities

• Plan, prepare, conduct, and report GMP and PV audits.
• Assess compliance with regulations, 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 development and improvement of quality systems and processes.
• Provide guidance and training related to QA/PV compliance when required.

Skills

GMP auditing

PV auditing

GxP knowledge

Analytical skills

Communication skills

Independent work

Attention to detail

English fluency

Education

Bachelor’s or Master’s in Life Sciences/Pharma/Quality Management

Tools

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
• 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.
• 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.