Project Supervisor

  • Location: Braine l'Alleud
  • Job #23952

Project Supervisor

Braine-l'Alleud – Contracting 

What do we expect from you? 

  • Partnering with engineering firms to ensure proper support in delivering the project designs & execution.
  • Working with our Business Expert to define the best solution to meet customer needs
  • Managing cost and planning for all engineering projects activities
  • Managing Basic / Detailed design and execution
  • Ensuring resources identified without gaps nor overlap
  • Handling project governance, budget controlling in accordance with PMO requirements (dashboard of multiple projects)
  • Overseeing the project team supervision (with Engineering company)
  • Consolidating and reviewing specifications (e.g. URS, Technical Specifications) with team project members and Engineering company
  • Ensuring strong communication with stakeholders and Engineering company
  • Supporting the communication structures for full collaboration between all parties involved in engineering projects to ensure two-way communication, engagement and collaboration
  • Dealing project engineering package of medium to high complexity

Are you the candidate we're looking for? 

  • Master's degree 
  • Minimum 5 to 10 years of engineering experience in project management
  • In-depth experience in a highly regulated environment
  • full professional proficiency in French and English (both oral and written)
  • ability to take initiative and work in a team environment
  • strong value commitment
  • experience in (complex/multiple) projects
  • both formal and informal leadership / coordination
  • experience with deployment of EPC (Engineering, Procurement and Construction) and EPCM (Engineering, Procurement and Construction Management) contracting models
  • manages with a matrix of reporting lines and across functional areas
  • ability to share good practices and knowledge
  • excellent communication skills and ability to prioritize multiple tasks and to work on multiple projects simultaneously.
  • Leadership experience for the management of internal and external resources
  • ability to apply previous learning and ideas to new situations, projects and teams, developing creative solutions to manage risk to a reasonably practicable level
  • strong reporting, interpersonal and leadership skills.
  • able to translate customers’ needs in projects requirements

What can we offer you? 

At Jefferson Wells, we offer you an indefinite contract, with a competitive salary commensurate with your experience (company car, meal vouchers, etc.). 

Do you want to know the rest of the recruitment process? 

If this sounds like you and you're keen to find out more, I urge you to apply! 

Then, in the next few days, a recruiter will get in touch with you to go through your CV and find out what motivates you. I promise, we're friendly! ☺

We can't wait to meet you, so don't wait any longer! 

Global Technical Assessment Lead for Equipment

  • Location: Braine l'Alleud
  • Job #23950

Global Technical Assessment Lead for Equipment

Braine-l'Alleud – Contracting 

What do we expect from you? 

  • Prepare and plan technical assessments with the various stakeholders (technical experts, HSE, area managers, engineering and maintenance, external companies, etc.) and assure to cover all the scope of the project by ordering complementary studies if needed.
  • Manage the assessment teams (composed of External suppliers and the company's internal profiles) at different stages of the whole process.
  • Coordinate the third parties on the shopfloor.
  • Understand expert’s report; Translate in the company risks and remedial actions by taking the lead of risk analysis teams.
  • Identify the critical risks, and lead the different teams to take the immediate and conservatory actions (ex : safety of people, business continuity, …)
  • Support the internal processes of identification, evaluation and rising of the company risks.
  • Consolidate/Resume the conclusion of the assessment in a final report (Excel charts, Powerpoint presentation, resume, …)
  • Report the progress status of the technical assessment project (KPI, progress, success, issues, risks, etc.)
  • Consolidate and compile standards information’s for equipment as obsolescence, lifetime, amortization period, …
  • Review the process of technical assessment after each step by improving/adapting continuously the way of working.
  • Collect and sort the documentation and information necessary to establish the project files: offers, technical specifications, Analysis, technical documentation, HSE documentation, risk analysis, reports, rationalize the actions plans, etc.

Are you the candidate we're looking for? 

  • Master's degree 
  • Medior or Senior profile required – Min 8 years of experience
  • Minimum 3 years within Project management
    • Minimum 5 of technical experience (e.g. Maintenance, Reliability, Technical project, SME,… )
    • Experience within chemical, pharmaceutical or biotech company is required
    • Minimum Experience with People management (external/internal) & stakeholders influence
  • Fluent in French with competencies in writing/reading in English.
  • Technical Expertise is required
  • Expertise in cGMP and HSE standards
  • Excellent written and verbal communications skill
  • Synthetize complex technical problematics for non expert public
  • Ability to manage priorities
  • Ability to work independently and in a matrixial organization
  • Must a self-driver for his responsibility Ability to take initiative Be flexible and open to change
  • Ability to work by people influencing
  • Problem solving
  • Fundamentals in people management (incl change, decisions, conflicts, coaching, leading, etc…).
  • Customers’ needs focused

What can we offer you? 

At Jefferson Wells, we offer you an indefinite contract, with a competitive salary commensurate with your experience (company car, meal vouchers, etc.). 

Do you want to know the rest of the recruitment process? 

If this sounds like you and you're keen to find out more, I urge you to apply! 

Then, in the next few days, a recruiter will get in touch with you to go through your CV and find out what motivates you. I promise, we're friendly! ☺

We can't wait to meet you, so don't wait any longer! 

CTS – Clinical Supply Associate

  • Location: Braine-l'Alleud
  • Job #23915

CTS – Clinical Supply Associate

Braine-l'Alleud – Contracting 

What do we expect from you? 

Basically, there is a higher level planning part and a more operational part:

  • The person we're looking for will log on every morning and check their emails. If there are any emergencies, he/she will have to jump on them. Once this emergency has been dealt with, we'll have to see if he/she has any packaging to request, etc. So, operational activities.
  • Another activity: do I have any documents to update? If so, you'll have to take action.
  • Planning part: is my supply plan aligned with clinical needs or do I need to launch a reassessment? If so, I'll get in touch with the stakeholders.

Are you the candidate we're looking for? 

  • Medior profile, 3-4 years of experience minimum (closed to less but not ideal and the profile must be very very good).

! Must have !

  • Organized.
  • Stress resistant.
  • Ability to switch from one activity to another.
  • Experience in supply is a must (with a pharma dimension if possible).
  • APICS certification: some knowledge of supply is essential.
  • -ENG mandatory.
  • Good communication skills.
  • Result oriented.
  • FR nice to have.
  • Experience in pharma is a BIG plus (it will influence our decision).

What can we offer you? 

At Jefferson Wells, we offer you an indefinite contract, with a competitive salary commensurate with your experience (company car, meal vouchers, etc.). 

Do you want to know the rest of the recruitment process? 

If this sounds like you and you're keen to find out more, I urge you to apply! 

Then, in the next few days, a recruiter will get in touch with you to go through your CV and find out what motivates you. I promise, we're friendly! ☺

We can't wait to meet you, so don't wait any longer! 

Master Data Operations Steward

  • Location: Braine-l'Alleud
  • Job #23870

Master Data Operations Steward
 

What are your responsibilities?

The position is responsible for ensuring that key product data is maintained accurately, efficiently and effectively.

Master data operations:

  •  Accountable for the complete product life cycle management:     

      o Manage and implement product launches:
                 – Manage the Business Case once approved
                 – Request the Finished Goods, Bulk and API codes in the MDM system
                 – Analyze and determine the relevant product flows to be used for any new product code in order to allow the correct execution of the business process                   

                 – Manage and coordinate the initial step in the collaborative workflow for code creation which will allow Forecasting and S&OP planning in OMP+
                 – Ensure correct master data set up in Supplying and Receiving plants in SAP
       o Manage the updates of non-printed components, bulk and API in the Bills of Material
       o Manage the product decommissioning

                 – Launch and manage the deactivation of Finished Goods and ensure tracking and coordination of the activities to ensure deactivation and closure of Track Wise and QMS actions in line with agreed due dates.

  • Compliance responsibilities

       o Change Controls:
                  – Ensure correct stakeholder review based on Master Data Business processes and requirements
                  – Ensure on time action, follow up and closure of action items
       o Deviations, Investigations and CAPAs
                   – Perform investigations for deviations
                   – On time action, follow up and closure of deviations, investigations and CAPAs

  • Project responsibilities:

       o Contribute to projects with master data impact by providing master data and business process expertise and input
Who are you?

  • Experience within the pharmaceutical industry and Supply chain knowledge
  • Knowledge of change control, deviation, etc.
  • Knowledge of SAP is a real plus 
  • Fluency in English, French is an asset
  • Service minded with good written and verbal communication skills
  • System and process oriented with high analytical skills
  • Structured, detail minded and well organized
  • Assertive with good influencing skills  
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.
 

Genesis Quality Partner

  • Location: Braine-l'Alleud
  • Job #23777

Genesis Quality Partner

Braine-l'Alleud – Contracting 

This team has already started installing the equipment, so they are looking for someone to join the team.

What do we expect from you? 

The installation concerns clean utilities (water loop, gas, etc.) and this team applies the oversight QA – qualification of the installations and then passes these qualified installations to the other teams : 

  • Experience in installing clean utilities equipment
  • Ability to challenge partners on validation/qualification
  • Pass on to operations
  • Team info: 3-person team well integrated into the Genesis project structure.

Are you the candidate we're looking for? 

  • Experienced profile preferred (minimum 5 years)

! Must have !

  • Experience in GMP clean utilities qualification (if other GMP production, we are ready to consider them).
  • Collaboration/team spirit
  • Ability to instill confidence (know how to get your ideas across without being pushy)
  • Stress resistant
  • Pharmaceutical experience is a must
  • Language: EN must have and FR nice to have

What can we offer you? 

At Jefferson Wells, we offer you an indefinite contract, with a competitive salary commensurate with your experience (company car, meal vouchers, etc.). 

Do you want to know the rest of the recruitment process? 

If this sounds like you and you're keen to find out more, I urge you to apply! 

Then, in the next few days, a recruiter will get in touch with you to go through your CV and find out what motivates you. I promise, we're friendly! ☺

We can't wait to meet you, so don't wait any longer! 
 

Compliance & Quality Systems Manager

  • Location: Braine l'Alleud
  • Job #23695

Compliance & Quality Systems Manager 

Braine-l'Alleud – Contracting 

What do we expect from you? 

Accountable/ responsible for ensuring the facilities is compliant with regulations and the standard quality systems in place, in collaboration with the owners of each individual area, which includes :

  • Access, confined areas and material and people flows through the facilities
  • Pest control management for the building (periodic visit and non conformity management)
  • Environmental monitoring (viable and non-viable) of the GMP areas and utilities, being the SPOC for the GMP manufacturing area and representative in the EM periodic meeting, managing asssessment of non conformities with stakeholders, suggesting actions and follow up with SMEs, reviewing/generating the periodic trending, keeping an eye on an optimal cleaning of the facilities.
  • Unexpected facility/environment event management (quick status, decision, quick actions plan and coordination with all the SMEs)
  • Risk management
  • Gowning process
  • Training of people on standard processes related to facilities and general quality systems
  • Highlight and prepare key topics and issues at Quality meetings 
  • Quality standards/regulations Gap analysis, risk and remediation plans management
  • Monthly Quality Lead Team meeting preparation and Lead
  • GMP training annual refresh for the Pilot Plant: collaboration on the content
  • Deviations and Change Controls management linked to all the listed systems, general quality topics
  • Continuous improvement management linked to all the listed systems, general quality topics

Are you the candidate we're looking for? 

  • Minimum Bachelor’s degree in sciences with min. 10 years experience in a regulated pharmaceutical area is required
  • Experience in production or quality, dealing with quality systems is required
  • Excellent understanding in GMP related environment
  • Experience with environmental monitoring is required
  • Experience in Biopharmaceutical is an asset
  • Experience dealing with Deviations and Change Controls
  • Foster lean and efficient processes, by continously challenging status-quo and striving for improvements

What can we offer you? 

At Jefferson Wells, we offer you an indefinite contract, with a competitive salary commensurate with your experience (company car, meal vouchers, etc.). 

Do you want to know the rest of the recruitment process? 

If this sounds like you and you're keen to find out more, I urge you to apply! 

Then, in the next few days, a recruiter will get in touch with you to go through your CV and find out what motivates you. I promise, we're friendly! ☺

We can't wait to meet you, so don't wait any longer! 

Quality Ops Partner

  • Location: Braine-l'Alleud
  • Job #23611

Quality Ops Partner
Contracting – Brabant Wallon 

Our partner is currently looking for a Quality Ops Partner to join its team. This international company is well-known for its pharmaceuticals.

What are your responsibilities?

You will be part of the Development Quality Pharma Operational team and will ensure the establishment, implementation, maintenance, and continuous improvement of an effective Quality Management System (QMS) linked to product development by :

  • Driving continuous quality improvement process, ensuring that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
  • Providing support to build the end to end “issued copy process’ for DEV/DSC entities.
  • Acting as Reconciler by checking the correct completion of the “issued Copy” process
  • Providing support during regulatory inspections, and quality improvement initiatives.
  • You will contribute the preparation of audits (internal/external, regulatory inspections)
  • Providing guidance and expert advice to development scientists, particularly with regard to the appropriate interpretation of national and international GMP regulations and guidelines
  • Identify, mitigate and subsequently resolve compliance and quality issues that may affect internal development activities and products.
  • Supporting QA activities for all Dev QA entities ( Lab, pilot plant,…..)
  • Maintaining and continuously improving Quality systems and processes in place for the appropriate documentation of internal development activities and ensure compliance with regulatory and corporate requirements.
  • Implementing and maintaining adequate Quality & Compliance Indicators and communicate results to appropriate levels of the organization.
  • Managing Quality meetings to maintain adequate level of compliance of the business activities.
  • Ensuring data integrity and compliance with regulatory requirements and industry best practices
  • Proactively support the activities of Development Quality Lead for relevant laboratory/manufacturing quality systems (deviation close out / change management/ complaints/ quality improvement).
  • Ensuring Development Quality Management System directly support Technical Operations and development partner goals and objectives.

Who are you?

  • You hold a master’s or bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, or Quality Management).
  • Minimum of 3 years of experience in data integrity and documentation control within the biopharmaceutical industry.
  • A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
  • QA/compliance experience in DS/DP/IMP manufacturing, facility operation, laboratory compliance and quality systems is an asset.
  • Good written/oral communication in English
  • Ability to work autonomously for the assigned activities with limited supervision
  • Must be able to act in most circumstances without direct supervision and handle complex/difficult situations.

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.
 

Vendor Quality Lead Drug Product

  • Location: Braine-l'Alleud
  • Job #23608

Vendor Quality Lead 
Contracting – Walloon Brabant
Our partner is currently looking for a Vendor Quality Lead Drug Product to join its team. This international company is well-known for its pharmaceuticals.
What are your responsibilities?

  • Being the central QA point of contact for the organization for investigations/deviations/ out-of-specifications/ audit observations associated with the assigned vendors.
  • Performing the QA review of deviation notifications and change controls, retrieving and collecting supportive information from involved stakeholders to allow assessment. 
  • Managing the key performance indicators for key operational QA activities and services associated with the vendors in the defined described tracking tools and track the vendor’s performance
  • Ensuring all Quality agreements are in place and take ownership of agreements for the vendors. Maintaining Quality Agreement with the vendors up to date and performing periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors.
  • When applicable, being sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the Stability Program
  • Ensuring the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensuring that this review is documented and made available in the Controlled Documents System.
  • Participating as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
  • Monitor and trend vendor performance including tracking of CAPA events and closure
  • Quality Complaints: Being the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensuring that initial receipt, logging of quality complaints into the Complaint System and provision of responses to the complainant are professionally coordinated and managed. 
  • If needed, working with the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Technical meeting. Coordinating vendor quality related investigations
  • Participating on ad-hoc basis to the Product Change Control Committees for activities related to the vendors and review change controls as QA stakeholder.
  • Providing expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
  • Working closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
  • Covering the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors
  • Owning of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
  • Ensuring all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
  • Ensuring review of relevant RA dossier section related to the assigned vendors
  • Having the overview of audit and HA inspections related to the vendors. Tracking and following-up on Audit observation and CAPA plan implementation at the vendor.
  • Being the QA stakeholder for Vendor Risk management. 
  • Managing and controlling quality documents related to the vendors in the Controlled Documents System
  • Providing support to customer audits and Health Authority inspections at the vendors, as needed
  • Receiving, coordinating, reviewing and authorizing product reworks and repackaging
  • Being the point of contact for post-release vendor quality issues (supply chain, distribution, etc.)

Who are you?

  • You hold a Master’s degree in scientific domain.
  • You have an experience within the pharmaceutical industry and in a Quality Assurance role.
  • You are familiar with aseptic processes.
  • You have an experience in root cause and risk management/assessment skills.
  • You have an experience in CMO management.
  • Knowledge of validation is a plus.
  • You are knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations.
  • You have good background knowledge of the pharmaceutical industry from a business and technical perspective.
  • You are able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
  • You speak fluently 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.
 

Product Supply Planning

  • Location: Braine l'Alleud
  • Job #23607

Product Supply Planning

Braine-l'Alleud – Contracting 

What do we expect from you? 

NPL activities

  • To help confirming nature of NPL and associated accountabilities and responsibilities under the lead of PVU Supply Chain
  • To help defining and improving routine process, templates, specifics in managing change controls for NPL under responsibility of Global Planning, together with PVU SC Integration
  • To orchestrate NPL supply readiness and changes in compliance with internal processes
  • To execute NPL associated activities per Global Planning ownership
  • To support Launch Excellence team for compliance to Launch Change control

Lifecycle Management activities

  • To assess Life cycle management (LCM) requests, support categorization to help defining associated accountabilities and responsibilities under the lead of Product Supply Planning Lead
  • To define and/or improve routine process, templates, specifics in managing change controls for LCM activities under responsibility of Global Planning, together with GSC Excellence
  • To orchestrate LCM supply readiness and changes in compliance with internal processes
  • To execute LCM associated activities per Global Planning ownership
  • Launch, Coordinate & Track Change control for execution

As part of the Global Supply Chain Community

  • To behave with discipline by strictly following defined processes, systems and supply governances
  • To be an ambassador of the company and Global Supply chain values in action
  • To continuously connect to the team and the community to keep improving business acumen
  • To embrace changes and ambition in enhancing GSC capabilities

Are you the candidate we're looking for? 

  • Master's Degree
  • You are fluent in French & in English 
  • 8-10 years minimum of experience in Supply Chain operations, Center of Excellence, or associated consulting domains with past proven experience in Tactical Planning activities, Product supply flows activation and New Product Launches in Pharma sector Experience in SAP, SourceCD, TrackWise preferred
  • Demonstrated E2E Supply Chain Professional Capabilities o Disciplined in critical GxP activities execution
  • Project management experience
  • Process and Analytical mindset, KPI and Result Driven
  • Demonstrated Capability of ensuring E2E visibility and accountability on an entire Supply chain flow
  • Good understanding of S&OP and Strategic Supply planning processes
  • Ability to learn fast within a complex environment

What can we offer you? 

At Jefferson Wells, we offer you an indefinite contract, with a competitive salary commensurate with your experience (company car, meal vouchers, etc.). 

Do you want to know the rest of the recruitment process? 

If this sounds like you and you're keen to find out more, I urge you to apply! 

Then, in the next few days, a recruiter will get in touch with you to go through your CV and find out what motivates you. I promise, we're friendly! ☺

We can't wait to meet you, so don't wait any longer! 

Global Logistic Specialist

  • Location: Braine-l'Alleud
  • Job #23537

Global Logistic Specialist

Braine-l'Alleud – Contracting 

What do we expect from you? 

  • Manage ordering process and coordinate transport activities related to the commercial products including transport planning, shipping documentation and customs declaration.
  • Act as a unique point of contact for a high-quality customer experience for the client and ultimately the patients
  • Build a strong relationship with local Supply Chain managers,
  • Be active and manage Markets queries by taking ownership/responsibility and liaising with the different internal departments if necessary,
  • Be proactive in identifying their needs and potential problems to continuously improve collaboration and provide the best possible service.
  • Collaborate with applicable stakeholders internally and externally: planning, commercial, finance, QA, master data, transport carriers, warehouse operators…

Are you the candidate we're looking for? 

  • You are fluent in French & in English 
  • You have 3 years experience in Supply Chain (logistic experience is a big advantage) within the pharmaceutical industry 
  • You have a good knowledge of SAP 
  • You have an experience in GMP 

What can we offer you? 

At Jefferson Wells, we offer you an indefinite contract, with a competitive salary commensurate with your experience (company car, meal vouchers, etc.). 

Do you want to know the rest of the recruitment process? 

If this sounds like you and you're keen to find out more, I urge you to apply! 

Then, in the next few days, a recruiter will get in touch with you to go through your CV and find out what motivates you. I promise, we're friendly! ☺

We can't wait to meet you, so don't wait any longer!