• Location: Braine-L'alleud
• Job #25492

Logistic Compliance Specialist

Brabant-Walloon – Contracting

Our partner is looking for a Logistic Compliance Specialist to join its team.
Your responsibilities?  

• Ensure Shipping Qualification is in line with the companies sop‘s and applicable referentials & standards (i.e. GDP, USP 1079, …),
• Animate Shipping Qualification project team and ensure shipping qualification deliverables are in line with the overall project milestones,
• Document shipping qualifications and associated documentation,
• Manage associated Change Controls.
• Get shipping Operational Qualification Report approved,
• Get shipping Performance Qualification Report approved ,
• Manage the creation of new datalogger set-up and update associated documentation,
• Ensure proper handling procedure is in place at supplier level,
• Report shipping qualification achievements and planning follow-up to project Core Team.
• Manage project change control(s), including impact analysis, submission to CC board and validation, follow-up in company eQMS…
• Manage Operational Qualification study:
• Write OQ protocol, manage review workflow, integrate comments, manage approval workflow,
•  Coordinate the study with the companies CLO (manage shipment requests, quotation, test execution follow-up, …),
• Write associated OQ report, manage review workflow, integrate comments, manage approval workflow,
• Write PQ protocol, manage review workflow, integrate comments, manage approval workflow,
• Coordinate PQ shipments with the supplier and internal stakeholders (including Global Logistics),
• Write associated PQ report, manage review workflow, integrate comments, manage approval workflow
• Manage datalogger set-up creation (SAP ref., Quality Agreement update, associated QA documentation update…),
• Set-up appropriate handling procedure and update relevant QA associated documentation for Global Logistics operations,
• Provide SME support and training to key stakeholders including supplier, Global Logistics Operations, Quality teams etc,

Your profile?

• Fluent in English,
• Working knowledge of GMP/GDP regulations,
• Proficient with qualification exercises,
• Understands basics of logistics operations,
• Ability to manage the “grey zone”, balance multiple priorities,
• Able to work within an international team environment and good team player.

• Location: Braine l'Alleud
• Job #25437

CMC Quality Solutions Specialist
Brabant Wallon – Contracting

Your responsibilities?
As Quality Solutions Specialist you will provide support to a group of CMC Quality Lead professionals relative to Quality Assurance activities associated with the lifecycle management for products commercially available or in late-stage development.

• Product Change Control Committee preparation and change controls follow-up
• Maintenance and lifecycle management of QA product flows
• Audits and Inspection anticipation and readiness
• Product metrics
• Review of Annual Stability Plan
• SOPs and other control documents writing, review and approval as needed
• Building and maintenance of Product QA knowledge (i.e., Product(s) SharePoint(s))
• Risk management and mitigation if applicable (e.g., follow-up on risk actions with QA stakeholders)
• Review and approval of CMC sections linked to regulatory original submissions, renewals or variations during any moment of the lifecycle management of the assigned products as needed
• Preparation and execution of Product launches from QA perspective (support in QA-RA assessment, support in QA activities, complaint readiness, shipping validation) as needed
• Product Quality Complaint Committee preparation and complaints oversight
• Product recall and product escalation meeting preparation
• Annual report (i.e., reporting of change controls to Health authorities…)
• Yearly Biological Product Report

Your Profile?

• Minimum of 3 years working in the pharmaceutical/biologics industry in a quality management position. Operational experience in GMP in Quality, Manufacturing or Quality Control would be an asset
• Fluent and confident use of English
• Knowledge in several areas of the global pharmaceuticals industry, including the interpretation and practical application of applicable regulations.
• Autonomy and adaptability
• Skilled and experienced in operating across cultures and in a multi-cultural environment
• Understanding of CMC Regulatory requirements

Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]

• Location: Braine-l'Alleud
• Job #25423

HSE Compliance Officer
We are looking for a motivated and experienced individual to join our team in the local support department in Belgium, within the Health, Safety, and Environment (HSE) service. Although the role touches on health and safety, it focuses primarily on environmental aspects. The position involves working on environmental projects and maintaining regulatory compliance across multiple regions (Wallonia, Brussels, Flanders).

The person will be responsible for managing environmental issues, including the “Licence to Operate” for our sites in HQ, Leuven, and Braine, in relation to environmental and urban planning permits. The individual will closely collaborate with the engineering team to ensure the necessary permits are obtained.

The Responsibilities

– Environmental Permits Management (Licence to Operate): Preparation, modeling, and data collection for the environmental and urban planning permits required for site activities
– Regulatory Compliance: Ensure compliance of installations with legal health, safety, and environmental requirements, especially regarding the risks associated with the storage of hazardous materials (CVZO).
– Environmental Projects: Track and manage environmental projects, including internal audits, measurement campaigns, and reporting to authorities.
– Environmental Management System: Maintain and improve our certified environmental management system. Participate in internal audits, measurement campaigns, and manage the administrative data related to environmental services.
– External Collaboration: Work with external consultants and experts to ensure effective environmental management and smooth communication with local authorities.

Skills and Knowledge Requirements

– Scientific Background: Degree in a scientific field with a specialization or relevant experience in environmental management.
– Environmental Management Experience: Experience in managing environmental issues, with good knowledge of local regulations (Wallonia, Brussels, Flanders).
– Administrative Knowledge: Ability to understand and follow environmental regulatory requirements and perform necessary reporting.
– Legislation Knowledge: Knowledge of environmental legislation in Belgium (Wallonia, Brussels, Flanders) is an asset.
– Languages: English is not required, but knowledge of Dutch is a plus, particularly for the Leuven site.
– ISO Certifications: Experience in an environment with a certified environmental management system (ISO 14001) is an asset but not a requirement.
– Flexible Working Hours: This position is a 50% replacement for the sick expert, with flexible hours (Tuesday, Wednesday, and Thursday mornings).
– Remote work is permitted when on-site presence is not required, but there are no fixed remote work days.
Additional Assets:
– Experience with Seveso risk management (hazardous materials storage).
– GMP (Good Manufacturing Practices) certification is a plus, but not required.
– Ability to ask questions and solve problems independently.

Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]