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
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!
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!
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.
CSV – IT Business Manager #CSV #IT #Manager #Pharma #GMP #CDI Vous êtes orienté CSV – IT et people management ? Vous avez d’excellentes connaissances des normes pharmaceutiques ? Alors ce qui va suivre va vous intéresser ! Notre partenaire, une entreprise pharmaceutique du Brabant Wallon, recherche un CSV – IT Business Manager Quelles sont vos responsabilités ? Gestion de l’équipe Business IT dans un environnement GMP
Gestion du personnel (soutien, évaluation, embauche).
Organisation de l'équipe et attribution des projets/tâches aux membres de l'équipe.
Participation aux audits des clients et aux inspections des autorités.
Définition des priorités en collaboration avec les responsables opérationnels.
Gestion des projets de validation de systèmes informatisés en environnement GMP
Planification détaillée du projet et des équipes de projet.
Gestion des budgets.
Coordination du projet.
Collaboration avec les services informatiques régionaux pour l'élaboration et la mise en œuvre des projets.
Représentation pour les projets pluridisciplinaires
Gestion des URS et les spécifications fonctionnelles.
Définition de plan de validation/test/protocoles.
Gestion de l'exécution des tests.
Rédaction des rapports et des procédures de validation.
Gestion des révisions périodiques.
Gestion du support fonctionnel aux applications
Définition des super user et des back up.
Gestion des change control et de l'interface avec l'informatique régionale.
Qui êtes-vous ?
Vous possédez un Master ou PhD scientifique et vous avez une affinité pour l’IT.
Vous avez une expérience confirmée en tant que chef de projet de validation dans l’industrie pharmaceutique.
Vous avez de très bonne connaissance de la validation des systèmes informatiques, du GAMP, du 21 CFR Part 11 et d'autres réglementations connexes.
Vous maitrisez le français et l’anglais.
Vous avez de l’expérience en gestion d’équipe.
Qu’offre l’entreprise ? Notre client vous offre un package salarial attractif complété d’avantages extra-légaux dont une voiture de société et l’opportunité d’évoluer au sein d’un groupe dynamique et innovant. Si vous êtes intéressé, n’hésitez pas à me contacter, via [email protected] Nous n’attendons plus que votre candidature pour discuter de votre projet professionnel.
The Vx Capital Investment team manages different portfolios of CAPEX projects in Belgium and Global Operations. The Capital Investment Definition and Start-up team is responsible to ensure all CAPEX projects definition phases and start-up phases are delivered according to plan with Safety & Quality standards as a priority. The team is also accountable for the adherence to the company engineering standards and practices in the projects. The project then goes in Execution, either in CAPEX Primary, CAPEX Secondary, CAPEX Tranversal or CAPEX Automation depending of the type of project. The position of Project Scheduler, critical to enabling the successful delivery of the pool of Projects and to manage the resources capacities, must be filled. The Project Scheduler reports to the Project Controller / Project Manager with the role continuing through end of Detail Design and Building Commissioning and Qualification.
Develop a project schedule to be implemented for the various phases of the Project life cycle with different detail level depending on the phase of the project (master schedule to level 4 schedule)
Challenge schedule provided by contractor (Engineering Office)
Regularly monitor progress against the project schedule and report any discrepancies to the Project Manager.
Participate in independent schedule reviews and incorporate findings
Participate in the risk management and analysis exercise and assess schedule impact of identified risks
Carry out schedule analysis to identify critical path and optimisation of same
Facilitate interactive planning for integrated schedule development
Ensure that all members of the Project Team are kept fully aware of the status of project schedules by reporting on progress, especially at key milestones
Extract critical path
Integrate the company schedule and contractor schedule in one integrated schedule
Participate in gate review
Play the role of scheduling tools (MSP, MSP online…) expert inside the Team and are the referent.
Provide support to the Project Managers part of the Team
Develop and regularly update the Project schedules for all the projects part of the Vx Project Management Team by collaborating closely with the different project managers to ensure that all monthly (project) reports are done in due time and in compliance with PMO the company standards.
Comply with the reporting requirements in place such as but not limited to, recurrent MS Project Online updates and project status updates.
Consolidate and extract the company resources workload forecast considering current projects from the company scheduling tools.
Extract key milestones for governance or Project Stage Gates by project/portfolio in order to allow the Team to anticipate the associated efforts and to increase the chance of success
Collaborate closely with the company PMO Teams
Liaise with other Project Team members and external contracting bodies as necessary to ensure the smooth flow of relevant information required for scheduling purposes.
Develop and maintain planning tools and documents in compliance with the company Project Management Framework.
Fill MSP Online reporting
To ensure that all activities within this responsibility are undertaken on time to allow the smooth progression throughout the Project from Initiation to Hand-over
Are you the candidate we're looking for?
Minimum Bachelor’s degree
Robust experience with planning with large, multi-level, international projects
Background in the pharmaceutical industry is a plus
CAPEX Project management experience as scheduler
PMP certification is a plus
Robust experience with preparation of presentation for senior management
Stakeholder management & influencing skills
Prior knowledge of the company standards & systems is a plus
Proven CAPEX project delivery experience within the company is a plus Soft Skills
Strong leadership skills & proven team management
Organizational skills
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!
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!
You have experience in quality assurance and validation in the pharma sector? You have an eye for details and for work well done? Keep reading your future job description.
Our partner is looking for a QA Validation to join its team. This international company is well-known for its pharmaceuticals and vaccines.
Your responsibilities?
As QA Validation, you will Provide QA support and oversight to validation activities according to validation procedures.
To take part in the establishment, the implementation, the follow-up and the maintenance of the continuous validation plan (CVP)
To define the validation strategies through the change control process
To write and implement some validation documentation (VP, VSR)
To review and approve specific qualification and validation documentation (IQ, OQ, PQ, Risk Assessment, Periodic validation)
To ensure the correct application of the validation quality systems on the field and to define improvement plan as required
To support the production & technical services teams in the implementation of the validation activities
To ensure an efficient and compliant CVP implementation
To provide a compliance and business expertise for some specific technical subjects
Challenge, review and approve qualification and validation (IQ,OQ, PQ, equivalence certificate, requalification protocol/report) documentation and ensure they are written in accordance with the internal standards and procedures
Write some validation (VP, PQ, VSR)
Review Periodic Validation Review documentation according to the company standards and procedures
Ensure timely escalation to Management of critical issues during validation and/or project
Pro-actively identify potential quality and compliance risks and be pro-active in escalation.
Attend all project meetings as QA expert from a compliance point of view the Manufacturing Unit Product & Process, Production and QA Operations for validation topics.
Your profile?
Engineering or scientific background (or equivalent acquired through professional experience)
Experience QA and Equipment’s Validation in a GMP Pharma environment
Understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety
Use a risk-based approach for problem solving and prioritization of tasks
Blow a quality and compliance mindset through the validation activities
Good communicator, autonomous and rigorous
Team player
Critical mind and quality oriented
French & 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.
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!
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 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.
