Qualified Person (QP)

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Job Description - Qualified Person (QP)

Qualified Person (QP) - Pharmaceutical Manufacturing

Role Overview

We are seeking an experienced Qualified Person (QP) to oversee the quality assurance and regulatory compliance of pharmaceutical manufacturing operations. The QP plays a crucial role in certifying batches of medicinal products prior to release for sale, clinical trials, or export, ensuring adherence to Good Manufacturing Practices (GMP) and relevant EU and Dutch regulations.

Key Responsibilities

  • Certify batches of medicinal products, ensuring compliance with GMP, Marketing Authorizations, and applicable laws
  • Evaluate the impact of deviations on product quality, safety, and efficacy, and participate in investigations
  • Approve subcontracted activities, review quality agreements, and oversee audits and self-inspections
  • Review and approve documentation, including change controls, validation protocols, SOPs, and annual reports
  • Participate in risk assessments, audits, and inspections
  • Ensure GMP aspects and the QP role are implemented in the quality management system and training programs
  • Coordinate and perform product recall operations as required
  • Represent the company in interactions with competent authorities

Qualifications and Experience

  • Diploma or certificate in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, or biology from a recognized university
  • Minimum of 2 years of practical experience in qualitative and quantitative analysis, and quality testing of medicinal products in a GMP-approved facility
  • Robust knowledge of EU GMP regulations, guidelines, and quality management systems
  • Experience as a certifying QP for solid unit dose products and Investigational Medicinal Products (IMPs)
  • Familiarity with quality assurance for sterile and narcotic products
  • Excellent communication skills in Dutch (C1 level) and English (C1 level)

Key Skills

  • Strong technical knowledge of EU GMP, regulations, and guidelines
  • Collaborative approach with ability to interact with cross-functional teams and regulators
  • Ability to work independently, self-driven, and results-oriented
  • GMP auditing knowledge and practical skills
  • Positive attitude, flexibility, and ability to work under pressure

If you meet the qualifications and are passionate about ensuring the highest quality standards in pharmaceutical manufacturing, we encourage you to apply for this critical role.

Please contact Max Jenner for more information on

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