Quality Specialist Clinical QP

Major responsibilities

• Review and assessQMS including policies SOPs and quality records
• Evaluate QMS alignment with applicable EU GMP requirements including those relevant for clinical trial manufacturing/importation
• Identify regulatory procedural and implementation gaps and define riskbased 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 inspectionfocused recommendations to support timely decisionmaking

Required Knowledge and skills

• Extensive experience in setting up a QMS
• Experience with requesting MIA license
• A QP certificate is not mandatory for this position but could be preferrable as this person may bring the necessary license requesting experience

• Strong knowledge of EU GMP requirements applicable to medicinal products and investigational medicinal products including the principles of the Pharmaceutical Quality System documentation production quality control outsourced activities deviations CAPA change control complaints recalls self-inspection and inspection readiness.
• Sound understanding of the regulatory framework for clinical trials in the EU including Regulation (EU) No 536/2014 and associated EudraLex Volume 10 guidance for clinical trial applications sponsor responsibilities and manufacturing/importation of investigational medicinal products.
• Detailed knowledge of Manufacturing and Import Authorization (MIA) requirements for the importation of medicinal products and investigational medicinal products into the EU/EEA.
• Good understanding of EU GMP Annex 21 on importation of medicinal products including the distinction between physical importation customs clearance site of physical importation site of QP certification.
• Detailed knowledge of EU GMP Annex 16 principles for Qualified Person certification and batch release.
• Understanding of the specific regulatory expectations for investigational medicinal products including appropriate control of manufacturing importation testing labelling storage transport release documentation and traceability prior to clinical use.
• Ability to interpret and apply EU and Belgian regulatory requirements in a pharmaceutical quality system including translating regulatory expectations into procedures quality agreements batch certification processes inspection readiness plans and risk-based remediation actions.
• Strong knowledge of batch documentation expectations for clinical products including batch manufacturing records analytical results deviations OOS/OOT investigations change controls temperature records transport records import documentation certificates of analysis and QP release evidence.
• Understanding of supplier and third-party oversight expectations including outsourced manufacturing testing storage transport quality agreements supplier qualification and the need to maintain adequate oversight across the importation and certification supply chain.
• Ability to assess gaps in procedures systems and records against EU GMP clinical trial importation and QP certification requirements.

Required Skills:

Audit ExpertiseGMP GuidelinesQuality ManagementRelease ManagementQMS