Qualified Person & Responsible Person (QP/RP)

Qualified Person (QP) & Responsible Person (RP) - Combined Role

Location: Leiden, Netherlands

Purpose of the Role

The QP/RP holds the legal responsibility to certify batches of Medicinal Product prior to release for sale and market distribution (Human and Veterinary) or prior to Clinical Trial use (Human only). Working closely with key personnel in production, quality control, quality assurance, and supply chain, the QP ensures that the manufacturer/importer operates in compliance with EU-GMP (Volume 4 Guidelines) and applicable EU and national legislation, including directives 2001/83/EC (as amended), 2011/62/EU, and national acts such as the Dutch Medicines and Opium Acts.

The QP is expected to be regularly present at operational facilities to ensure compliance and maintain oversight. The responsibilities must be personally fulfilled, with the QP remaining continuously contactable. Duties may be delegated, but not responsibilities.

Organizational Reporting

• Reports to: General Manager / Lead Qualified Person
• Representative during absence: Qualified Person

General Responsibilities

• Certify and release medicinal product batches in accordance with GMP, MA, and EU/Dutch laws.
• Ensure QP certification adheres to the terms of the MIA and EU GMP Annex 16.
• Evaluate deviations for potential impact on product quality, safety, or efficacy.
• Maintain QP certification records.
• Prevent uncertified batches from being added to saleable stock.
• Approve subcontracted activities impacting GMP and sign related quality agreements.
• Ensure regular self-inspections and audits of subcontractors are performed.
• Approve quality-related documents (SOPs, protocols, APQRs, etc.).
• Participate in risk assessments, audits, and inspections.
• Draft and sign QP Declarations for regulatory use.
• Decide on disposition of rejected, recalled, or falsified products.
• Ensure customer GMP complaints are managed and investigated.
• Support integration of GMP requirements and QP role in the QMS and training.
• Notify management of GMP compliance issues.
• Coordinate product recalls with appropriate stakeholders.
• Ensure compliance with national legal requirements (e.g., Opium Act).

Authorities

• Halt operations if found non-compliant with GMP, MA, or MIA.
• Approve or reject raw materials, packaging, and final products.
• Approve GMP suppliers and manufacturers and sign related contracts.
• Authorize GMP documentation.
• Notify MAH and authorities of suspected falsified products.
• Serve as company representative with national and international authorities.
• Initiate recalls with approval from authorities.
• Notify authorities of violations related to the Opium Act.

Legal Requirements

As per Directive 2001/83/EC Article 48:

• Must hold a diploma from a recognized university course ( 4 years) in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical sciences, or biology (Pharmacists typically preferred in the Netherlands).
• Must have 2 years of practical experience in GMP manufacturing, covering qualitative/quantitative testing of active substances.
• Must be accepted by Dutch health authorities and listed on the MIA ("Fabrikanten vergunning").

Key Skills

• In-depth knowledge of EU GMP and regulatory compliance.
• Experience in an EU QMS and with sterile/solid dosage forms.
• Strong collaboration with cross-functional teams (QA, RA, MAH, regulators).
• Independent, results-driven mindset with auditing skills.
• Good communication, flexibility, and ability to work under pressure.
• Experience with narcotic product quality assurance is advantageous.
• Minimum C1 proficiency in both Dutch and English.

Working Conditions

• Office-based with remote work flexibility.
• Travel mainly within the EU, occasional international trips.
• Reports into the Lead QP (NL).