Quality Specialist Clinical QP

We are seeking a Quality Specialist – Clinical QP for a consultancy mission at a client site, representing Keystone Solutions. In this role, you will assess and strengthen the Quality Management System (QMS) in alignment with applicable EU GMP requirements, supporting inspection readiness and the Manufacturing Import Authorization project.

• →Review and assess the current QMS, including policies, SOPs, and quality records.
• →Evaluate QMS alignment with applicable EU GMP requirements for clinical trial manufacturing/importation.
• →Identify regulatory, procedural, and implementation gaps and define risk-based priorities for remediation.
• →Actively lead the Manufacturing Import Authorization (MIA) project as a quality subject matter expert.
• →Support preparation for Health Authority inspections related to the MIA application.
• →Ensure inspection readiness of critical quality systems such as document control, training, deviation management, CAPA, change control, supplier oversight, and batch documentation.
• →Support alignment of processes and procedures to enable QP certification of clinical products.
• →Collaborate closely with QA Operations, Qualified Person, Regulatory, Manufacturing, and other key stakeholders.
• →Provide clear, pragmatic, and inspection-focused recommendations to support timely decision-making.

• Extensive experience in setting up a QMS.
• Experience with requesting MIA license.
• A QP certificate is not mandatory, but preferable for necessary license requesting experience.
• Strong knowledge of EU GMP requirements applicable to medicinal products and investigational medicinal products.
• Sound understanding of the regulatory framework for clinical trials in the EU, including Regulation (EU) No 536/2014.
• Detailed knowledge of MIA requirements for the importation of medicinal products into the EU/EEA.
• Good understanding of EU GMP Annex 21 on importation of medicinal products.
• Detailed knowledge of EU GMP Annex 16 principles for Qualified Person certification and batch release.
• Understanding of specific regulatory expectations for investigational medicinal products.
• Ability to interpret and apply EU and Belgian regulatory requirements in a pharmaceutical quality system.
• Strong knowledge of batch documentation expectations for clinical products.
• Understanding of supplier and third-party oversight expectations.
• Ability to assess gaps in procedures, systems, and records against EU GMP, clinical trial, importation, and QP certification requirements.

• Audit Expertise - Level: Expert - Most recent: Any time
• Clinical Medicinal Products - Level: Advanced - Most recent: Any time
• GMP Guidelines - Level: Expert - Most recent: Any time
• License request experience - Level: Advanced - Most recent: Any time
• Quality Management - Level: Expert - Most recent: This year
• Release Management - Level: Expert - Most recent: This year
• Set up of QMS - Level: Expert - Most recent: Any time

Dutch or French
Level Nice to have
English
Level Full professional proficiency