Review/Approve the validation documentation regarding the GMP requirements and the Vaccines procedures
Ensure that production practices are aligned with validation conclusion
Attend all project meetings as QA validation representative
Ensure timely escalation to Management of critical issues during validation
Contribute to the deviation process providing QA oversight and approving deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities
Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
Work in autonomy with supervision/coaching
To define the validation strategies through the change control process
To write and implement some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review ….)
Let's talk about you !
You hold a Master’s Biotechnology, Agronomy, Chemistry or Pharmacy
You have experience with SAP
You have knowledge of GMP’s standards
You have good communication skills to be the only point of contact between other stakeholders
You are Fluent in French and able to speak and understand 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.
You’re interested in this job? We kindly invite you to apply.
You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Aurélie Montes Suarez: [email protected] or +32472/44.83.18
Our partner is looking for an Supply Network Planner – DS (Drug Substance) to join its teams. This international company is well known for its pharmaceutical products.
Your responsibilities?
Production MPS Planning
To build and deliver a feasible MPS plan for one or several production nodes on the MPS time horizon (18M+) and PrO and PO hand over to production partners
To use the company adopted Advanced planning tool – OMP+ and SAP – to build monthly/weekly MPS where applicable – based upon Anaplan input developed by E2E products planners
Ensure that production plans are in line with customer requirements, stock policies and E2E S&OP products planners plans
In charge the Distribution Replenishment plan (DRP) for managed products. Collaborate closely with Global distribution & logistics for managing day-to-day operations.
Run the capacity reconciliation assessment, identify gaps, find solutions with partners, vendor teams or site local planners and escalate to S&OP level if required. Set in place ad hoc capacity review (S&OP) with production sites (CMO and internal)
To manage all transactional data into the system for his/her dedicated assets based plan calculated at tactical level
Control execution of the plan over the frozen and MPS horizon
Ensure that production plans are in line with previous production step availability
Manage potential changes of plans in the frozen horizon
To manage the supply risk on the short and mid-term horizon in collaboration with markets, TPA PVU Supply, Vendors, QA and E2E product planners;
To create STO once stock is available and communicate with logistics
To plan & coordinate with production and schedulers all restamps, reworks, validations, maintenance stops and availability of batches under deviations.
To manage change controls linked to planning activities
To consolidate Inventory requirements (Projection, Provision & Destruction) and be main point of contact for different functions
Production nodes (CMO and internal sites) Supply Performances Management :
In charge of weekly supply performances monitoring and analysis on defined KPI’s definition (OTIF, ATP,..). Responsible to facilitate the supply performances discussion within the Vendor team and with partners.
In charge Root cause analysis (Measure, Analyze, Improve and Control), primary performances lead in the vendor teams.
Responsible for leading performances management into the Tier departmental structure and on-site if any
Production nodes (CMO) Capacity planning: development of capacity/capabilities views for each production nodes, support to elaboration of future mutual supply agreement with CMO. Active participation to SIOP cycle (pre-SRM, SRM, IR), participation to capacity extension projects and initiatives with production nodes rep with the vendor team. Alignment on capacity assumptions SAP/OMP to E2E Product planner tactical scenario planning and decision
Escalation Resolution: lead escalated supply issues resolution on production nodes with support of the vendor team and the supply network lead. Is accountable to update stakeholders on supply impact, resolution, figures and will support issue resolution acceleration within vendor team and the production sites representatives (hot topics, hypercare,…)
Planning integration : integration of input to supply plans, scenario planning, feeding decision making, support supply issues resolution
Process & Systems enhancement: drive and provide inputs to supply center of excellent (SC CoE), global planning and global distribution to ensure right process and system governance execution and propose improvement initiatives when needed (planning, order fulfillment, forecasting, performances management, etc…)
Partnering: accountable for creating relationship and trusted collaboration channel with supply chain representative of production sites, improve and sustain ways-of-working according to guidance and Network management playbook. Participate actively to vendor teams meeting and OMR.
NPL & LCM : Master Data Readiness, Artwork readiness (labelling implementation), PO – MPS alignment, Readiness of DS batches for next step, Readiness of DP batches for next step, Readiness of Devices for next step, Readiness of FG batches for initial mfg + packaging, Production sequence agreement, Confirmation of initial supply (volumes and delivery dates), Samples agreements – Launch (FG/DP/DS)
Digitalization & Innovation : support innovation & digitalization initiative in partnership with GSC teams (SC CoE), CMO network Steering co up to project execution start
Manage Network Change: Input to Business Case, Vendor supply agreement creation, Capacity model definition, Critical parts definition, CMO operating strategy alignment, Align CMO segment, Translate CMO segment requirements into operating choices
Risk Management & Escalation flow : accountable for ensuring governance of risk management governance for CDMO network of what is beyond operational short term risks (provide inputs, assessments, mitigation) for tier-1 up to key tier-2 or tier 3 suppliers.
Your profile?
Bachelor's or Master's Degree
Certification (Describe): APICS fundamentals
Language skills : Fluent in French and English
Background in pharma Operations and/or Planning experience. Technical skills in associated manufacturing process is a plus
Performances Driven
Systems skills in SAP/OMP (or fast learner)
Experience or willingness to the manufacturing operational environment
Stakeholder management, skills to influence
Able to manage Details and complexity
Clear in oral and written communication (English)
Analytical mindset, KPI and Result Driven
Demonstrated Planning and constraint management capabilities
Ability to learn fast within a complex environment
Rigorous person, able to go from High view to very detailed view
Ability to influence others at all level of the organization
Capable of challenging ideas and providing Feedback in a constructive way
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. You can contact Noémie Sheta : [email protected]
Our partner is looking for an Global Distribution Specialist to join its teams. This international company is well known for its pharmaceutical products.
Your responsibilities?
Follow up on low cover items and proactively co-ordinate with Planning to ensure timely delivery of products
Act as intermediary between the company Markets and supplying sites
Monitor daily open stock transfer orders for the company Markets
Analyze latest market/country information to understand mid and long-term supply requirements
Create deliveries (upon shipping schedule in place) and daily follow-up on shipments
Organization of transports and preparation of necessary documentation related to shipments, organized in accordance with the specific instructions of each customer, packaging site and inter-company customer including hazardous goods requirements when applicable, including for TPA deliveries
Choose optimal mode of transport based on customer’s request and list of validated vendors
Control transportation costs against agreed rate cards and spot quotations when required
Co-operation with external/internal WHs for the control and monitoring of receiving, storage and order preparation operations, including the management of Idocs related to these activities.
Provide local Supply Chain managers with regular updates on their coming replenishments
Address complaints to appropriate departments in charge and follow up if necessary
Handle returns from the company Markets to supplying sites
Execute contractual reconciliations or price transfers
Issue Credit/Debit Notes where applicable
Maintain client working instructions in Global Customer Service database & commercial client files in SAP for the company Markets
Contribute in launch preparation for individual portfolios
Participation in operational meetings within GL
Calculation and monitoring of KPIs followed during Tier meetings
Maintain proper and accurate Pre-Shipment and Post-shipment Administration
Management and follow-up of each customer's specific logistic instructions via customer file
Knowledge of relevant SOPs and supporting systems (eg. ColdStream, Trackwise, Qlik)
Your profile?
Bachelor's Degree
3-5 years’ experience in area of: Customer Service, Logistics, Warehouse operations, Transportation
Language skills : Fluent in French and English
Customer Service oriented
Functional knowledge of Supply Chain processes
Knowledge in transportation and Warehousing, preferably in the Pharmaceutical industry
Knowledge in Good Distribution Practice, Cold Chain Distribution, Incoterms and understanding of customs clearance processes.
Experience with any ERP, Office (strong focus on Excel), SAP is a strong advantage
Stress resistant, analytical, flexible, able to work independently, strong team spirit, excellent verbal and written communication skills and customer focused
Exceptional organizational skills
Excellent attention to detail
Experience within the context of an international organization
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. You can contact Noémie Sheta : [email protected]
Notre partenaire, une entreprise internationale connue pour le développement et la production de médicaments, recherche un Analyste QC pour renforcer ses équipes.
Vos responsabilités ?
Vous effectuez le contrôle des produits pharmaceutiques finis en vrac ou conditionnés conformément aux instructions de travail et procédures préétablies.
Vous participez à la tâche de planification, et donc, assurez avec l’aide du superviseur le suivi du planning de manière à respecter les délais impartis sur chacun des lots à analyser.
Vous veillez aux stocks de consommables et recommandez/signalez en temps et en heure le matériel nécessaire au fonctionnement du laboratoire pour éviter tout arrêt d’activité.
Vous participez à la mise en place et à veillez au respect du programme de housekeeping/5S du laboratoire.
Vous participez activement dans les investigations à mener lors de résultats analytiques non-conformes ou aberrants.
Vous proposez au Responsable du laboratoire toute mesure (choix d’appareil, de réactifs, de méthodes, organisation du travail, modification de procédures, besoins en training, etc.) permettant de réduire les délais et coûts d’une part, et d’améliorer la précision et l’exactitude des essais d’autre part.
Vous participez au programme de maintenance et/ou de qualification de l’appareillage du laboratoire.
Votre profil?
Graduat, Bachelier, Master ou équivalent dans les domaines de la Chimie, Biochimie, Biologie.
Une expérience préalable dans un environnement soumis aux normes GMP, BPF, ICH est un requis.
Une expérience préalable dans un département Contrôle Qualité est requise (minimum 2 ans d’expérience).
Le requis pour cette fonction est une connaissance approfondie des techniques d’analyse biochimiques telles que : le Bioassay (comprenant notamment : passage cellulaire, gestion des master cell bank/ working cell bank, analyse de type « cell based assay »), L’ELISA, la qPCR, etc…
Une maîtrise de la manipulation sous conditions aseptiques
La connaissance de Trackwise ou software équivalent pour la gestion des déviations et LIMS ou équivalent pour la gestion des échantillons est un atout.
Une bonne connaissance de l’anglais technique lu et écrit est un atout
Vous aimez travailler en équipe avec un grand sens de l’autonomie et du respect.
Vous êtes focalisé sur l’amélioration continue avec un solide état d’esprit orienté qualité et « green »
Le département Contrôle Qualité nécessitant parfois des délais très courts, vous avez la capacité de bien gérer le stress si nécessaire et d’être flexible
Notre offre ? Nous vous offrons un contrat à durée indéterminée ainsi qu’un package salarial attractif. Vous profiterez également de l’opportunité de vous développer personnellement et professionnellement à travers des formations internes.
Data Reviewer Contracting Our partner is looking for a Data Reviewer to join its teams. This international company is well known for its pharmaceutical products. Your responsibilities?
Perform data review in support of product characterization, release and stability for an extended series of techniques: chromatography, dissolution, karl fisher, particle size, UV, IR, NIR, titration etc
Ensure compliance with all relevant regulatory regulations, analytical methods and specifications, GMP and safety.
Scientific evaluation of generated results
Let's talk about you!
You hold a master’s degree in science or bachelor with relevant experience
Good knowledge and practical experience with any analytical technique is an asset
Ensure high quality standards for experiments and take on responsibility for these experiments.
Efficient, flexible and dynamic
Excellent communication skills
Customer focused and result performance driven
Sense of Urgency
You have a good knowledge of English, both spoken and written
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.
Complaints Specialist Our partner is looking for a Complaints Specialist to join its teams. This international company is well known for its pharmaceutical products. Your responsibilities?
Carrying out, documenting and reviewing the complaints, including evaluating the possible impact on the patients and providing an answer to the hospital / care provider / patient.
Guaranteeing the correct balance statement by investigation level per type of complaint. It is important to be able to differentiate between product-related complaints that are specific to the product and process-related complaints, which can be caused during our production process and thereby rationalize the appropriate level of research.
Monitoring and follow-up of the trending of complaints on a daily, monthly, quarterly and annual basis. By using the necessary statistical tools and mapping the complaint ratio. Based on this, an evaluation is made of the need to start up additional actions with the intention of reducing the complaint ratio.
In the case of process-related complaints, act as a facilitator between the involved departments, work with experts from production, product support and other departments and lead the cross-departmental meetings on this and guarantee that the investigation is conclusive.
Ensure notification to higher management regarding significant quality issues and complaints and corrective & preventive actions taken.
Ensure complaint management in a timely manner and in accordance with PQS, GMP and relevant medical device and combination products requirements.
Respect the PGS vision, mission, values and leadership behaviors in order to realize the PGS objectives related to quality, GMP, customer satisfaction, right first time.
Let's talk about you!
Strong written communication skills: for technical reports
Analytical skills (data analysis)
Persuasiveness: you can bring different parties together to arrive at the best possible solution
Good time management and prioritizations skills
Team player
Proven problem solving abilities
Talen (Languages):fluent in Dutch 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.
Our partner is looking for a Formulation Scientist to join its team. This international company is well-known for its pharmaceuticals.
Your responsibilities?
Supporting the development of formulation of monoclonal antibodies through the application of manufacturing (buffer exchange) and analytical techniques (H/UPLC, cIEF, UV spectroscopy, DLS, CGE, etc.).
Preparing formulations of antibody for stability studies and collecting experimental data following established analytical methods.
Writing accurate and precise experiment records, for all activities following Good Scientific Practices.
Helping to generate study protocols and reports to justify the selection of preferred NBE formulations.
Your profile?
Biotechnology, Biology or Analytical (bio)chemistry degrees.
Min. 2 years of industrial experience, experience with analytical techniques and/or formulation, ideally with proteins/antibodies derived molecules.
Practical laboratory skills with HPLC/UPLC (especially size exclusion), cIEF, UV/Vis spectroscopy, DLS, CGE, rheology, etc.
A working knowledge and practical laboratory experience of antibodies and their formulation, including freeze-drying.
Experience or interest in protein structural modelling is a plus
Experience in writing accurate and precise experiment records
Experience with data analysis and interpretation, protocols and summary report writing would be a plus.
Technical English is mandatory.
Familiar with a creative, flexible, fast pace and stimulating environment in a multidisciplinary team.
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.
Our partner is looking for a Sr Specialist Change Control Management to join its teams. This international company is well known for its pharmaceutical products.
Your responsibilities?
Execution of PES supplier change control processes in conformance to current standards and procedures, using applicable system application tools.
Ensure integrity, consistency and compliance of processes for JSC globally.
Assure successful implementation of changes and actions by following up and synchronizing activities for all participants, communicating status for implementations to key stakeholders
Provide product and Supply Chain knowledge to ensure proper implementation and compliance
Partner with other areas of Supply Chain and actively develop and manage relationships with process users, business owners, affiliates and external organizations.
Let’s talk about you !
Bsc in Physical or Life Science; Supply Chain and/or Chemical Engineering
3-5 years of related experience, including significant experience in pharmaceutical or other related highly regulated industry
Min. 3 years’ experience in leading virtual teams
Strong Project Management Skills
Demonstrated experience to lead complex change implementations confidently.
Demonstrated understanding of manufacturing processes and associated GMP compliance requirements. Able to apply this knowledge to lead and develop change control process strategies for global needs
Demonstrated understanding of global Regulatory Affairs legislation and Regulatory Compliance requirements. Able to apply this knowledge to evaluate changes and assess potential risk introduced to the business as result of changes
Ability to engage and align with other diverse and dispersed organizations and functions.
Ability to negotiate, influence and lead without direct line authority.
Ability to engage others and lead an organization through continuous improvement and change.
Excellent communication skills
Have attention to detail and are organized; follow and establish processes
Proficient in written and spoken English and Dutch
Ability to work independently
Ability to understand the content of changes
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.
Global Quality Lead Support Brabant Wallon – contracting
Our partner is looking for a Global Quality Lead Support to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
This position provides support to a Global Quality Lead relative to Quality Assurance activities associated with the lifecycle management for a product transitioning from Development to Commercial by:
Product Change Control Committee preparation and change controls follow-up, quality review for change proposals related to the product life cycle management.
Maintenance and lifecycle management of QA product flows
Audits and Inspection anticipation and readiness
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
Who are you ?
You already worked in GMP environment for 5 years
You are experienced in operating across cultures and in a multi-cultural environment
You have experience in GMP audits and inspections would be an advantage
You are Fluent in French and your English is not bad
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.
QA Document Support Word jij onze nieuwe ambassador? Jefferson Wells Life Sciences is gespecialiseerd in de ondersteuning van farma & biotech bedrijven in hun dagelijkse uitdagingen. Vandaar onze interesse in experts zoals jij om ons team te versterken. Laten we samen kijken naar jouw eerste challenge bij ons!
Takkenpakket?
Beheer van:
Documentatie
Deviatie & CAPA
Change Control
Health, Safety & Environment
Quality Third Party
Audit management
Complaint management
Risk management.
In het kader van dit project, hebben wij een opdracht vacant voor documentatie relateerde taken binnen een GMP kader. De opdracht omhelsd oa:
voorbereiden en updaten van documenten ism de document owner
processen van documenten in het documentatiesysteem
Account management
voorbereiden van master data, ism de data owner
Profielverwachtingen?
Je hebt 1-2 jaar ervaring in GMP omgeving/gecontroleerde documentenbeheer
Je bent vlot in het NL/ENG
Je bent Nauwkeurig
Je bent Doelgericht
Je bent zelfstarter/initiatiefnemer
Je bent communicatief vaardig
Je bent een teamplayer
Je hebt ervaring in digitale tools
Wat kan Jefferson Wells voor jou betekenen? Als ambassador krijg je de kans om te groeien binnen internationale bedrijven waarin je een sterk netwerk kan opbouwen. Door een persoonlijke opvolging krijg je een kwaliteitsvolle ondersteuning in elke stap die je onderneemt. Tot slot geniet je van de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen aan de hand van interne trainingen en opleidingen. Heb je interesse in deze functie? Aarzel dan zeker niet en solliciteer nu met jouw cv!