Qualified Person

pAkkodis is a global engineering and technology consulting company supporting organizations in the development, transformation and optimization of their products, systems, and operations. Our experts work across engineering, digital and software, Data AI, manufacturing, and life sciences, contributing to projects in sectors such as mobility, aerospace, energy, and healthcare. At Akkodis, you join an international environment where you can develop your expertise, work on challenging projects and build a career that evolves with your ambitions. /p h3Your Responsibilities /h3 pAs a Delegate Qualified Person (QP), you will play a key role in ensuring the quality, compliance and regulatory readiness of pharmaceutical and clinical trial materials. /p ul liPerform batch release and QP certification activities in accordance with EU regulatory and GMP requirements. /li liEnsure Clinical Trial Materials comply with applicable GMP requirements, product specifications and approved regulatory documentation. /li liReview, assess, investigate and approve deviations and change controls. /li liReview and approve relevant QP release and certification documentation. /li liSupport the management of retest date extensions and study or country additions. /li liMonitor GMP and GDP quality metrics and identify potential quality risks. /li liProvide QP oversight for activities falling under the responsibility of the Quality organisation. /li liLead and participate in quality and QP-related projects and improvement initiatives. /li liParticipate in regulatory inspections and audit readiness activities. /li liSupport and participate in external partner audits and internal self-inspections. /li liEnsure appropriate CAPAs are implemented, monitored and assessed for effectiveness. /li liCollaborate closely with Quality Assurance, Regulatory Affairs and other internal quality organisations. /li liSupport quality activities involving external collaboration and alliance partners. /li liEnsure appropriate escalation of critical quality and regulatory issues. /li liSupport product retrieval and other quality-related activities where required. /li liContribute to the continuous development of a strong quality and compliance culture. /li /ul h3Your Profile /h3 ul liScientific Master's degree in Pharmacy. /li liQualified Person (QP) background or qualification allowing the candidate to perform Delegate QP responsibilities. /li liMinimum 1 year of professional experience within a pharmaceutical environment. /li liGood knowledge of EU GMP and GDP requirements. /li liExperience with batch review, batch release and pharmaceutical quality systems. /li liKnowledge of deviations, CAPA and change control management. /li liStrong understanding of pharmaceutical regulatory and quality requirements. /li liExperience supporting audits and regulatory inspections. /li liStrong analytical skills and a quality-driven mindset. /li liAble to interact effectively with Quality, Regulatory and external partners. /li liAutonomous, rigorous and comfortable taking responsibility for critical quality decisions. /li liFluent written and spoken English is mandatory. /li /ul h3Nice to Have /h3 ul liExperience in pharmaceutical production or manufacturing. /li liExperience in ATMP manufacturing. /li liExperience with Clinical Trial Materials. /li liExperience performing QP certification or batch release activities. /li liExperience with regulatory inspections and external partner audits. /li liKnowledge of requirements related to international product release. /li liExperience in Pharmaceutical RD or Drug Quality Management. /li /ul h3Practical Details /h3 pEnvironment: Pharmaceutical / Clinical Development /p pThe position involves close collaboration with Quality Assurance, Regulatory Affairs and external manufacturing or collaboration partners. /p h3What we have to offer /h3 pAt Akkodis, we want to give you the right environment to develop your expertise and grow throughout your career. You can count on: /p ul libA permanent contract /b /li libAn attractive compensation package /b, including 13.92 months of salary /li libA company car or mobility budget /b, depending on your package /li libA flexible cafeteria plan /b /li libTraining and development opportunities /b to strengthen both your technical and professional skills /li libA structured onboarding and regular follow-up /b, including career discussions and support from your managers /li libAccess to technical communities and experts /b to exchange knowledge and develop your expertise /li libReferral and business bonuses /b when you contribute to growing our teams and business /li libOpportunities to develop your career /b across different projects, technologies, and areas of expertise /li /ul