Quality Compliance Officer - GDP

Internetwork Expert; Rueil-Malmaison; Sur place; EUR 45 000 - 65 000; Plein temps

Résumé du poste

A leading company seeks a Quality Compliance Officer to oversee compliance activities within their regional cluster. The position involves maintaining quality management systems, performing batch releases, and ensuring adherence to regulatory standards. Ideal candidates hold a pharmacist degree and have substantial industry experience, ready to make an impact in ensuring product safety and compliance.

Qualifications

• Relevant pharmaceutical industry experience.
• Experience supporting successful regulatory inspections.
• Good knowledge of regulatory requirements, GMP/GDP.

Responsabilités

• Maintain Norgine's regional clusters quality management systems.
• Perform batch release for products before distribution.
• Generate regional compliance metrics and contribute to risk reduction strategies.

Connaissances

Influencing

Communication

Relationship Building

Data-driven Decision Making

Formation

Pharmacist degree with professional qualification

Outils

Quality Management Systems

Description du poste

Want a 3D Career? Join Norgine.

At Norgine, our colleagues dare themselves to be different, drive to achieve their goals and beyond, and develop themselves and their community.

We call it the 3D career at Norgine, offering a fully-rounded experience with no limits.

Bring everything about yourself that you’re proud of—whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity—to unleash your potential in a fast-paced environment and supportive community.

In return, you gain a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.

Because at Norgine, we transform lives with innovative healthcare solutions.

We have an exciting opportunity for a Quality Compliance Officer to join Norgine.

The person in this role will report to the Quality Compliance Manager.

The Quality Compliance Officer supports the Regional cluster France & BeNeLux with regards to Good Distribution Practice (GDP) and product compliance activities.

RESPONSIBILITIES

• Maintain Norgine’s regional clusters quality management systems under RP/Quality affiliate oversight, focusing on authorized activities and record accuracy and quality.
• Act on behalf of Norgine’s regional cluster for delegated duties concerning regional Wholesale Distribution licenses, complying with EudraLex Vol 4, European Commission Guidelines on GDP, and French regulations.
• Perform batch release for products before distribution.
• Follow up on shortages or risks of shortages for major therapeutic interest and declare them to relevant stakeholders.
• Generate regional compliance metrics, identify noncompliance and risks, and contribute to risk reduction strategies with clear action plans.
• Serve as Responsible Person (RP) for GDP on the Norgine NV Wholesale Distribution license, ensuring compliance with relevant guidelines and regulations.

MAIN TASKS

• Maintain quality management systems and records for the regional cluster.
• Keep records of delegated duties and activities.
• Perform delegated duties concerning regional WDA licenses.
• Ensure suppliers and customers are approved.
• Manage recalls when necessary.
• Maintain initial and ongoing GDP training programs.
• Conduct and participate in self-inspections and ensure corrective actions.
• Support data generation and management reviews.
• Participate in inspection readiness activities and external inspections.
• Develop and manage quality documents and KPIs.
• Approve subcontracted activities impacting GDP.
• Adhere to additional product-specific legal requirements.
• Archive GDP information according to records retention procedures.
• Support RP/GDP teams to uphold responsibilities.
• Assist in revising SOPs, WI, forms, and templates related to GDP.
• Handle customer complaints effectively and record them.
• Manage deviations, CAPAs, change controls, and drug shortages.
• Support batch documentation and release processes.
• Prepare documentation, update trackers, and communicate internally and externally.

EXPERIENCE

• Pharmacist degree with professional qualification and RP status.
• Relevant pharmaceutical industry experience.
• Experience supporting successful regulatory inspections.
• Good knowledge of regulatory requirements, GMP/GDP, and distribution environment.
• Strong influencing, communication, and relationship-building skills.
• Experience with Quality Management Systems and KPI reporting.
• Ability to make data-driven decisions based on scientific evidence.

Key Committee Memberships include:

• Responsible Persons Forum
• Affiliate Management Review
• Business and Quality Review Meetings

Our benefits vary per location. Please contact the Norgine TA representative for more information.

Interested? Find out more about your career with Norgine and apply now.

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