• Location: Wavre
• Job #22312

Validation Engineer

Brabant Wallon – Contracting 

Our partner is looking for a Validation Engineer to join its team. This international company is well-known for its pharmaceuticals and vaccines.

Your responsibilities?

As a Validation coordinator, you will be working for the Product and Process department. You will directly report to the Validation Manager and support him implementing different projects.

• Actively participate in the definition of project including (validation plan & strategy);
• Define the entire scope of the project, in charge of the planning and coordinator of the change control.
• Ensure the change control
• Collect, analyze and write the IOQ/PQ validation protocols and reports and analyze the results during PQ runs linked to the different validations
• Ensure the planning of the validations in partnership with C&M/QA and production departments + contingent (C&M)
• Ensure the communication with the different stakeholder to achieve the scope of the project
• Ensure the operational management of the technicians dedicated to the validations
• Ensure all deviations related to the implementation of the change
• Ensure the follow up/reporting of the project within the MPU and outside the MPU via the ad hoc flows of communication (PRB – TIER…)
• Ensure the follow up of the QC / C&M results for each run of validation
• Ensure the collection/transfer of the local approved documents to the RA department on time in order to ensure the file submission on time
• Ensure the review of the file preparation in partnership with the QA before the file submission to the authorities
• Schedule adherence for the project
• Success rate for validations and submission on time to avoid major impact on batch release/supply

Your profile? 

• You hold an University Degree in biotechnology, agronomy, chemistry, pharmacist or engineering 
• At least 3 years in pharmaceutical industry, in manufacturing, validation, QA
• Sound knowledge of project management
• Practical knowledge of MS project, Excel, SAP, techshare
• Fluent in English written and spoken.
• Experience in communicating to various stakeholders
• Experience in highly regulated environment 

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.

• Location: Wavre
• Job #22146

Clinical R&D Leader
Brabant Wallon – Contracting

Our partner is looking for a Clinical R&D Leader to join its team. This international company is well-known for its pharmaceuticals and vaccines.

Your responsibilities?

• Contribute to activities or components of a Clinical and Epidemiology Plan (CEP) as appropriate
• Define the outline and content of the protocol,
• Analyse and interpret the results as a subject matter expert..
• Assure that results meet the highest standards of quality and ethical conduct.
• Support to Independent Data Monitoring Committee (IDMC)
• Assumes accountability for the medical/legal and human safety aspects of the clinical study. (If not an MD, assembles and transmits timely summaries of clinical safety data for review by competent medical officer).
• Responsibility for Data Listing review for the medical portion of data listing for individual studies, assure medical consistency within trial and across trials within program.
• Address scientific and medical issues related to one or more clinical studies. Pay special attention to serious adverse events occurring during clinical trials and potential safety signals.
• Publishes clinical data in peer review journals and presents in external scientific meetings / congresses.
• Maintains and expands knowledge in medical and scientific competencies (as appropriate), vaccinology and trial methodology.
• Contribute to development of clinical section of regulatory files, including labeling.

Your profile?

• You hold a Master or a PhD secializing in the field of pediatrics, obstetrics and gynecology, infectious diseases, clinical epidemiology, or pharma-co-epidemiology.
• You have knowledge and understanding of vaccines, clinical research, and biomedical research regulation, including ICH and GCP.
• You have at least 5 years experience within the pharmaceutical industry
• You have good knowledge of analytical techniques  
• You are a proactive thinker and problem solver
• You speak French and English

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. 
Do you have any questions? You can contact Aurélie Montes Suarez: [email protected] or +32472/44.83.18

• Location: Wavre
• Job #22084

Admin Master Data Entry 

Brabant Wallon – Contracting 

Your responsibilities ? 

• Ensure the transfer (copy/past) of risk data (about 800 risks) from xls files to a computerized system (Veeva QMS).
• Initiate a data approval process in the Veeva QMS system.
• Use of Excel and Veeva QMS software for which training will be given to the person.
• Communicate with local site Risk Expert in English in case of questions via Teams and Outlook.
• Report on project progress to relevant stakeholders and escalate any concerns
• Follow up action items for progress

Your profile ? 

• Fluent in English as risks are written in English and communication with sites should be in English too
• Project Management skills to demonstrate the progress of the transfer activity
• Tech savvy – knowledgeable of excel and quality systems (ideally Veeva), Teams, Outlook.
• Reliable individual
• Self-motivated; Sense of urgency
• Good communication skills and good organization skills
• Customer focused; ability to understand requirements of sites and project team
• Ability to adapt, work under uncertainty and accommodate flexible work demands
• Global perspective; cultural sensitivity
• Result-oriented and proactive work style

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. 

• Location: Wavre
• Job #22077

QC Product coordinator support 

Brabant Walloon – contracting

Our partner is looking for a QC Product coordinator support to join its team. This international company is well-known for its pharmaceuticals and vaccines.

Your responsibilities?

• Write working instructions and procedures related to sample transfer at low temperature
• Assemble the necessary data and information to issue rationale to support sample holding time before testing
• Compile data in comprehensive power point presentations
• Gather necessary information to complete sampling impact assessment in change control were QC Sampling & Sample Management SME is involved 

Your profile?

• Master or PhD Scientific university degree (Engineer in Chemistry, biochemistry, or Pharmacist,…)
• You have an experience working in cGMP environment
• You have wide knowledge and experience of analytical methods on biopharmaceuticals
• SAP knowledge is a plus
• Knowledge of change control processes is a plus 
• Analytical mindset 
• Documentation and scientific rigor
• You have writing skills in English

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.

• Location: Wavre
• Job #22053

GMP Compliance

Wavre – contracting 

Our partner is looking for a QA Regulatory Compliance to join its team. This international company is well-known for its pharmaceuticals and vaccines. 

What are your responsibilities ? 

• Review and/or approval of variations/submissions/RTQ/Commitment + provide technical support to GRA
• You support Manufacturing Performance Units or Quality Control Department for CMC processes
• On quality oversight of source documents and providing operational documents to support GRA in authoring post approval changes' variations
• Review, on behalf of Operations, submitted documents to Health Authorities in the frame of Regulatory Submission Process.
• Support Questions & Answers and Commitments process within Manufacturing Performance Units or Quality Control Department.
• Support QA and MPU head in the prioritization of the CMC subjects in their area
• You oversee Change Control
• You provide technical support to Global Regulatory Affairs (GRA) in communication to and from Health Authorities in the frame of post approval changes management.
• You provide CMC and regulatory conformance expertise to support release of products in compliance with marketing authorization through deviation assessment, visibility to registered details, post approval changes guidance.

Let's talk about you ! 

• A scientific background
• A knowledge of legislation related to license acquiring and post approval changes management
• A knowledge of the CMC dossier and GMP
• Technical understanding of product manufacturing processes and/or testing
• Good knowledge in English
• Sense of urgency, flexibility and accountability Enterprise thinking (cross functional team spirit)
• Strong quality and results oriented mindset, Assertive, Lean culture spirit

Preferred Qualifications:

• If you have the following characteristics it would be a plus:
• Demonstrated ability to quickly understand end to end process
• Demonstrated ability to take full accountability of small or medium project
• Good analytical and problem-solving skills

What can you expect?

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. Do you have any questions? You can contact Marie Rossenfosse : [email protected] 

• Location: Wavre
• Job #22025

Validation Engineer

Brabant Walloon – contracting

Our partner is looking for a Validation Engineer to join its team. This international company is well-known for its pharmaceuticals and vaccines.

Your responsibilities?

• Act as an actor/coordinator of innovation projects
• Participate in prototype development with suppliers / internal technical teams.
• Author qualification documents (URS, IQOQ…) and participate in qualification activities
• Support technical discussions with suppliers in order to compare available technologies and identify pro’s and con’s
• Collect and compare site specifics needs and follow project across a network of sites.
• Summarize progress and highlights key elements.
• Ensure documentation, minutes and reports are produced in a timely manner and shared with the appropriate stakeholders.
• Challenge strategies and help to build a path into pragmatic strategies (qualification, way of working, …)

Your profile?

• Scientific university degree (Engineer in Chemistry, biochemistry, or Pharmacist,…)
• Experience in Automation / Robotization projects
• Experience within QC or R&D laboratory environment
• Qualification of lab instruments or robotic systems
• Experience in Machine learning processes (Deep learning) and Vision systems is a plus

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.

• Location: Wavre
• Job #21943

Quality Agreement Manager

Brabant Walloon – contracting

Our partner is looking for a Quality Agreement Manager to join its team. This international company is well-known for its pharmaceuticals and vaccines.

Your responsibilities?

• Soliciting, collecting, negotiating, and reviewing proactively quality agreements in partnership with key stakeholders (procurement/ TLCM/ manufacturing sites).
• Providing support in generating and managing the annual Quality Agreement plan for the company in partnership with Pharma and R&D.
• Escalating any quality agreement issues to direct management and supplier quality operations team for further negotiation with suppliers. 
• Compiling and coordinating risk assessments related to Quality Agreements issues.
• Obtaining and maintaining relevant supplier information in company systems in a systematic manner to allow for effective and efficient utilization of supplier data.
• Collaborate in the simplification projects for the Qualification and lifecycle management of Incoming material
• Interfaces – Routinely interfaces with site Quality /Procurement, Audit & risk Management, SQ Operations and the company suppliers – a two-way communication regarding supplier compliance documents, quality agreements, change controls, etc

Your profile?

• You have an higher education degree with scientific background.
• You have an experience in the negotiation of Quality Agreement
• A work experience in a GMP environment (min 2-3 years), preferably in a pharmaceutical company, is required.
• Strong command of English. Command of French is an asset. 
• Good verbal and written communication skills, including ability to progress requests for information in an effective manner.
• Proficient influencing and negotiating skills to ensure collection of desired information from suppliers and user sites while maintaining a good relationship with the supplier.
• Awareness and understanding of local and global regulatory requirements regarding subjects such as animal derived materials, residual solvents etc.
• Good time management skills to ensure assigned activities and associated documentation are completed within the required timelines.

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.