Senior Qualified Person — Batch Release & Compliance (EU)

Akkodis; Wallonië; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Permanent contract

13.92 months of salary

Company car or mobility budget

Flexible cafeteria plan

Training and development opportunities

Structured onboarding and regular, go‑

Career discussions and manager support

Access to technical communities and专家

Job summary

Akkodis is seeking a Delegated Qualified Person (QP) to ensure quality, regulatory readiness, and compliance of pharmaceutical materials. You will perform batch release, review deviations, support CAPA, and coordinate QP documentation within a collaborative Quality and Regulatory Affairs environment.

This role requires a Scientific Master’s in Pharmacy, a QP background or the ability to perform Delegate QP duties, and at least 1 year of pharma experience.

Qualifications

• 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.

Responsibilities

• 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.

Skills

English (fluent)

Analytical skills

Quality mindset

Autonomous

Stakeholder collaboration

Education

Master's degree in Pharmacy

Job description

Akkodis is seeking a Delegated Qualified Person (QP) to ensure quality, regulatory readiness, and compliance of pharmaceutical materials. You will perform batch release, review deviations, support CAPA, and coordinate QP documentation within a collaborative Quality and Regulatory Affairs environment.

This role requires a Scientific Master’s in Pharmacy, a QP background or the ability to perform Delegate QP duties, and at least 1 year of pharma experience.