Qualified Person

Akkodis 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.

Your Responsibilities

As 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.

• Perform batch release and QP certification activities in accordance with EU regulatory and GMP requirements.
• Ensure Clinical Trial Materials comply with applicable GMP requirements, product specifications and approved regulatory documentation.
• Review, assess, investigate and approve deviations and change controls.
• Review and approve relevant QP release and certification documentation.
• Support the management of retest date extensions and study or country additions.
• Monitor GMP and GDP quality metrics and identify potential quality risks.
• Provide QP oversight for activities falling under the responsibility of the Quality organisation.
• Lead and participate in quality and QP-related projects and improvement initiatives.
• Participate in regulatory inspections and audit readiness activities.
• Support and participate in external partner audits and internal self-inspections.
• Ensure appropriate CAPAs are implemented, monitored and assessed for effectiveness.
• Collaborate closely with Quality Assurance, Regulatory Affairs and other internal quality organisations.
• Support quality activities involving external collaboration and alliance partners.
• Ensure appropriate escalation of critical quality and regulatory issues.
• Support product retrieval and other quality-related activities where required.
• Contribute to the continuous development of a strong quality and compliance culture.

Your Profile

• Scientific Master's degree in Pharmacy.
• Qualified Person (QP) background or qualification allowing the candidate to perform Delegate QP responsibilities.
• Minimum 1 year of professional experience within a pharmaceutical environment.
• Good knowledge of EU GMP and GDP requirements.
• Experience with batch review, batch release and pharmaceutical quality systems.
• Knowledge of deviations, CAPA and change control management.
• Strong understanding of pharmaceutical regulatory and quality requirements.
• Experience supporting audits and regulatory inspections.
• Strong analytical skills and a quality-driven mindset.
• Able to interact effectively with Quality, Regulatory and external partners.
• Autonomous, rigorous and comfortable taking responsibility for critical quality decisions.
• Fluent written and spoken English is mandatory.

Nice to Have

• Experience in pharmaceutical production or manufacturing.
• Experience in ATMP manufacturing.
• Experience with Clinical Trial Materials.
• Experience performing QP certification or batch release activities.
• Experience with regulatory inspections and external partner audits.
• Knowledge of requirements related to international product release.
• Experience in Pharmaceutical R&D or Drug Quality Management.

Practical Details

Environment: Pharmaceutical / Clinical Development

The position involves close collaboration with Quality Assurance, Regulatory Affairs and external manufacturing or collaboration partners.

What we have to offer

At Akkodis, we want to give you the right environment to develop your expertise and grow throughout your career. You can count on:

• A permanent contract
• An attractive compensation package , including 13.92 months of salary
• A company car or mobility budget , depending on your package
• A flexible cafeteria plan
• Training and development opportunities to strengthen both your technical and professional skills
• A structured onboarding and regular follow-up , including career discussions and support from your managers
• Access to technical communities and experts to exchange knowledge and develop your expertise
• Referral and business bonuses when you contribute to growing our teams and business
• Opportunities to develop your career across different projects, t