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!
Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team.
Let's look together at your first challenge with us!
Scope of work:
Technology transfer, initial process validation and process control strategy definition for introduction of new products and processes at manufacturing scale
Identification of process improvements to increase yield or process robustness, and generation of a supportive data package leading to implementation at manufacturing scale
Supporting and safeguarding existing production processes by data trending and monitoring, generation of scientific/technical study protocols and reports in support of significant changes, product impact assessments upon significant deviations in the production process and provided technical advice to questions of other departments
Profile:
You have a PhD or master in Life Sciences, with relevant experience of minimum 3 or 7 years, respectively, in process development or MSAT-like functions
You are fluent in writing and talking in English
You have specific experience in protein purification (on lab- and/or manufacturing scale);
experience with growing mammalian cells in bioreactors is a plus
You are flexible and a strong communicator, who is able to connect, go in discussion and find compromise with people in other departments or sites
You have an excellent analytical and problem-solving mindset, are accurate with the necessary eye for detail
You are familiar with various statistical and data trending techniques
You like to work in team and consider yourself to be a good team player.
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.
Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team.
Let's look together at your first challenge with us!
Scope of work:
Creating electronic batch records (EBRs) for the introduction of a new products in LAUNCH plant 1.
Edit and proof work to ensure high editorial standards are met across all content outputs
Responsible for configuring production processes in the MES system (PAS-X)
Translating production processes to a Master Batch Record (MBR) in the MES system
Collaborate with the creative team to assess project needs and help with messaging
Drive brand consistency across all company communications
Develop and implement brand guidelines
See projects through the whole creative lifestyle, from inception to deployment
Profile:
You hold a bachelor's degree or are equivalent through experience
You have knowledge of MBR design (PAS-X) or an equivalent system
You have a strong written and oral communication skills, both English and Dutch.
You can work both independently and in a team. You have good interpersonal skills
You can work according to plan
You have sufficient ability to independently translate process-related activities (CIP, SIP, Leaktest, media, buffer and process steps) to a Master Batch Record (MBR) in the MES syste
You have experience as MBR designer/Author
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.
Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team.
Let's look together at your first challenge with us!
Scope of work:
Support designing/developing/improving/validating existing analytical methods in function of existing or new production processes
Independently set-up experiments and develop and carry out studies in Cell & Biochemistry-oriented teams
Provide documentation through generation of scientific/technical study protocols and reports
Maintain, adjust, and communicate documentation and knowledge.
Data trending and monitoring of ongoing methods, experiments, and analyses to ensure reliability, as well as have an accurate understanding of the effectiveness and efficiency of the methods
Profile:
You obtained, preferably, a PhD in Life Sciences or are equivalent through experience
You have a very good knowledge of English, both written and oral
you are an expert in binding assays, capillary electrophoresis, spectrophotometric, plate based assays (ELISAs) etc. and driven to execute assays in the lab
You have excellent problem-solving skills (escalate where needed) and can handle multiple (practical) tasks at the same time
You have good technical writing skills and are able to prepare protocols and reports
You are accurate, result-oriented, and able to critically analyze data, draw scientifically sound conclusions, and formulate them correctly
You have an excellent knowledge of cGMP and can convert legal requirements regarding analytical methods into effective action plans
You are a team player and have good communication skills
You are flexible, stress-resistant, open to change & innovation, and used to working within deadlines
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.
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:
Uitvoering van zowel microbiologische als chemische analyses in het QC labo onder GMP condities, in 16/7 werkschema
Afhankelijk van je werkdomein krijg je een opleiding in de verschillende technieken die uitgevoerd worden samen met de operationele analysten
Compliance Training uitvoeren volgens het leer plan, voorafgaand uitvoering van de taken.
Alle afwijkingen van de geimplementeerde procedures dienen gemeld te worden
Taken worden uitgevoerd conform de afgesproken planning in de operationele QC groep.
Profiel:
Bachelor in een wetenschappelijke of Life Science richting, biotechnologische of microbiologische achtergrond is zeker een pluspunt
Je bent bereid in een 16/7 schema te werken, (vroege 6-14u; late 14-22u, week en weekend)
Je bent in staat Engelse instructies te kunnen uitvoeren.
Basis kennis van GMP rules of een gelijkaardig kwaliteitssysteem is een vereiste
Je beschikt over goede communicatieve vaardigheden, en overlegt met teamleden de workload.
Je bent leergierig zodanig dat je de achtergrond van de analyse technieken begrijpt, waardoor je variabel werkt compliant kan uitvoeren.
Je doet graag verschillende analyse technieken (vb microbiologische membraan filtratie, endotoxine plate methode, TOC, pH, conductiviteit, uitverdelen van stalen).
Relevante ervaring is een pluspunt, maar geen must gezien interne opleiding voorzien wordt.
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
Our partner is looking for a QA Engineer Alliance Products to join its teams. This international company is well known for its pharmaceutical products.
Your responsibilities?
Key Responsibilities:
Ensure GMP compliance products manufactured and/or tested at a contract facility.
Ensure all aspects of product manufacturing and/or testing are reviewed versus established
Quality standards and the applicable marketing authorizations.
Manage quality systems, e.g. change control, deviations, and product investigations.
Modify, review, and ensure contractor quality standards and protocols for processing materials into partially finished or finished products meet Sanofi and GMP requirements.
Contribute to the completion of milestones associated with specific projects.
Core Responsibilities:
Review batch abstracts to release products in accordance with approved specifications and procedures.
Monitor contractor compliance via GxP documentation review and on-site visits/audits.
Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter Expert review.
Interact with multi-functional internal and external project teams to ensure compliance.
Respond to technical and quality issues and handle schedule and/or process-related conflicts.
Demonstrate understanding of applicable regulations related to the manufacture of medicinal products (biologics).
Manage notification flows in quality systems between internal and external partners
Monitor contractor performance to establish Key Performance Indicators (KPIs) and report adverse trends.
Provide guidance to less experienced staff, as applicable.
Your profile?
Bachelor’s or Master's degree and 3-5 years of experience in a cGxP or other regulated environment, whereof 3 years in a quality role. Experience in a regulatory affairs (RA) role is a plus
Excellent communication and organizational skills.
Demonstrated ability to perform work requiring attention to detail and of high quality (i.e. right first time).
Being fluent in English is a requirement (writing & speaking), Dutch 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.
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!
Verantwoordelijkheden:
Opstellen en reviewen van Quality documentation in kader van project (Project notes, Quality plannen, …)
Opvolgen en reviewen van general project documentation (risk assessments, validatie plannen, procedures, batch records, …)
Quality ondersteuning en expertise delen met betrekking tot klinische manufacturing en commercial manufacturing
Project documentatie (e.g. procedures, risk assessments) opmaken en reviewen met oog op deviation prevention (DPP) and human error prevention (HEP)
Compliance zijn met SOP’s, globale standaarden, regulations en product registratie (filing) met betrekking klinische en commerciele manufacturing
On the floor GMP support, inclusief uitvoeren van GEMBA’s.
Cross-departementele samenwerkingen ondersteunen
Weten wanneer issues/QA events geëscaleerd dienen te worden naar supervisor/manager
Profiel:
Master in een wetenschappelijke richting of gelijkwaardig door ervaring
Kennis en interpretatie van cGMP in een gereguleerde omgeving
Kennis en interpretatie van klinische manufacturing en regulations is een voordeel
Kennis en ervanring met Quality Processen en Quality Assurance
Uitmuntende nauwkeurigheid en oog voor detail
Zelfstandigheid en een sterk verantwoordelijkheidsgevoel
Een enthousiaste teamplayer en sterk in communicatie
Goede writing skills
Goede kennis van de Engelse taal
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
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!
Verantwoordelijkheden:
Reviewen en opvolgen van master batch records en EBR’s in MES en op papier
Suporteren bij Implementatie van real-time exception review
Opvolgen, reviewen (en behandelen) van minor QA events en batch records met focus op deviatie preventie, i.e. identificeren en aandacht hebben voor human error preventie initiatieven
Ondersteuning van het QA 24/7 team in hun dagelijkse werking, alsook opvolging van taken over de shiften heen
On the floor GMP support, inclusief uitvoeren van GEMBA’s.
Cross-departementele samenwerkingen ondersteunen
Reviewen en opvolgen van declassificaties, inclusief vernieuwde werkwijze mee implementeren en opvolgen
Opvolging van QA review van werkorders
Weten wanneer issues/QA events geëscaleerd dienen te worden naar supervisor/manager
Profiel:
Je behaalde een bachelor/master diploma in een wetenschappelijke richting
Je bent vlot in het Nederlands zowel mondeling als schriftelijk
Je bent flexibel
Je werkt autonoom
Je bent kritisch en nauwkeurig
Je bent een goede teamplayer
Je hebt een sterke communicatie
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!
Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team.
Let's look together at your first challenge with us!
Scope of work:
Development of second-generation processes for existing commercial products using small scale models for studies conducted in lab environment
Technology transfer, initial process validation and process control strategy definition for introduction of new products and processes at manufacturing scale
Identification of process improvements to increase yield or process robustness, and generation of a supportive data package leading to implementation at manufacturing scal
Supporting and safeguarding existing production processes by data trending and monitoring, generation of scientific/technical study protocols and reports in support of significant changes, product impact assessments upon significant deviations in the production process and provided technical advice to questions of other departments.
Profile:
You have a strong affinity with working in a lab environment,
You have (preferably) a PhD in Life Sciences, with relevant in process development or MSAT-like functions,
You have fluent English speaking and writing skills, knowledge of Dutch is a plus,
You have specific experience with growing mammalian cells in bioreactors; either on lab- or production scale,
You have an excellent analytical and problem-solving mindset, are accurate with the necessary eye for detail and can handle multiple tasks at once,
You have excellent writing technical/scientific writing skills (protocols & reports),
You are flexible and willing to support both manufacturing scale operation and set up small scale lab studies,
You have knowledge of cGMP,
You are a strong communicator, who is able to connect, go in discussion and find compromise with people in other departments or sites,
You like to work in team and consider yourself to be a good team player,
Flexibility, stress resistance, openness to change & innovation and eagerness to meet deadlines are characteristics of you.
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.
Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team.
Let's look together at your first challenge with us!
Job Description
You will be in a biopharmaceutical manufacturing site of therapeutic proteins. These proteins are produced through cell culture processes in bioreactors, followed by a purification process. The Manufacturing Science and Technology department (MSAT) provides the scientific backbone to enable the use of these complex biotechnological processes.
The focus of the here described function is on the upstream cell culture part of the process. Starting from thorough scientific and technical knowledge, you contribute to improvement and monitoring of existing processes on site and the broader network through:
Supporting and safeguarding existing production processes by data trending and monitoring, generation of scientific/technical study protocols and reports in support of significant changes, product impact assessments upon significant deviations in the production process and provided technical advice to questions of other departments.
Identification of process improvements to increase yield or process robustness, and generation of a supportive data package leading to implementation at manufacturing scale
Modeling & data analytics in support of investigations, data monitoring, process improvements and gaining additional process knowledge
You have (preferably) a PhD in Life Sciences or Chemical engineering, with relevant in process development or MSAT-like functions
You have fluent English speaking and writing skills, knowledge of Dutch is a plus
You have specific experience with growing mammalian cells in bioreactors; either on lab- or production scale
You have experience with and an exploratory mindset towards modeling, data analytics and statistics (e.g. Matlab, JMP, SIMCA,…)
You have an excellent analytical and problem-solving mindset, are accurate with the necessary eye for detail and can handle multiple tasks at once
You have excellent writing technical/scientific writing skills (protocols & reports) You are flexible and willing to support both manufacturing scale operation and set up small scale lab studies
You have knowledge of cGMP
You are a strong communicator, who is able to connect, go in discussion and find compromise with people in other departments or sites
You like to work in team and consider yourself to be a good team player.
Flexibility, stress resistance, openness to change & innovation and eagerness to meet deadlines are characteristics of you.
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.
