38 jobs voor qc support gevonden

The QC Support technician, CAR-T Manufacturing is an executing function with responsibilities within QC area related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

Major Responsibilities:

You will support the daily QC analyses:

- You will control, disinfect and clean the materials/equipment needed for the QC analyses.

- You will help out with the internal transfer of the materials from the logistic center to the in process lab.

- You will help out with the handling of the waste from the lab.

- You will support the transport of the samples (QC release, QC retain, EM) at different temperatures (room temperature, cooled transport).

- You will support the EM analyses in grade C and grade D.

- You will utilize an electronic system (LIMS) for execution and accurate documentation of the disinfection and cleaning of the equipment or document your performed tasks in a correct way in logbooks and forms.

- You execute the activities in a strictly regulated environment.

- You perform tasks in a manner consistent with the safety policies, quality systems and c.GMP requirements.

- Other duties will be assigned, as necessary

Bedrijfsprofiel:

This company is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases.Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy.From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Support GMP activities in the laboratory such as

• Change control creation and follow up
• Actions follow up
• Training matrix review and documentation
• Protocol, study execution and report for compendial feasibility
• Update/review of laboratory documentation: analytical methods; analytical instructions; coaching's modules,…
• Ensure follow-up and compliance of procedures and instructions, and update if needed.
• Ensure follow-up of corrective actions and preventive actions.
• Support product launches and prepare documentation requested by authorities
• Update of batches documentation according to specifications
• Support documentation linked to in process analyses

▪.‘Getting the job done together’, samenwerking met de QC Employee. ▪ Het borgen, naleven en uitdragen van het kwaliteits én veiligheidsbeleid binnen de QC afdeling;.▪ Het inspireren, instrueren en trainen van QC Employees;.

Als Analytical Support Engineer ben je verantwoordelijk voor methodeontwikkeling, validatie en transfer projecten.Je schrijft en beoordeelt protocollen en rapporten en fungeert als aanspreekpunt bij analytische vragen van andere afdelingen en Project Managers.

Als Analytical Support Engineer zal je verantwoordelijk zijn voor:

• Methodeontwikkeling,validatie en transfer projecten waarbij je onder andere protocollen en rapporten schrijft en beoordeelt.
• Ben je het aanspreekpunt bij analytische vragen van andere afdelingen en de Project Managers.
• Je geeft advies en werkt mee aan optimalisatiemogelijkheden binnen het labo en zet actief mee je schouders onder deze projecten.
• Je bent het eerste aanspreekpunt en biedt ondersteuning aan de Project Managers omtrent analytische topics of vragen bij introductie van nieuwe producten.
• Je beoordeelt de haalbaarheid en implementatie van analysemethodes in het labo en formuleert voorstellen over de mogelijke strategie voor analytische projecten.
• Je wordt ingeschakeld als (analytical) reviewer van protocollen en rapporten van procesvalidatie,cleaning validatie en stabiliteit.
• Je beoordeelt de impact van change requests op het labo in samenspraak met de QC & Stability Manager

Bedrijfsprofiel:

Voor een klant in de farmaceutische sector in Bornem zijn we op zoek naar een Analytical Support Engineer.

Uitvoeren van specificatiebeheer, beheren van nieuwe normen en opstellen van werkinstructies..Organiseren van interne opleidingen rond kwaliteit en hygiëne, en geven aan collega's..

Als Analytical Support Engineer ben je verantwoordelijk voor methodeontwikkeling, validatie en transfer projecten.Je schrijft en beoordeelt protocollen en rapporten en fungeert als aanspreekpunt bij analytische vragen van andere afdelingen en Project Managers.

Providing support and expertise to specific projects led by your team or stakeholders (e.g.implementation of a new regulations, coordination of stability studies to support a process change, support submission readiness for various geographies …) .

Recruits, trains, and contributes to retention efforts of employees..Conducts technical training and development of staff as needed..

Estée Lauder Companies is een wereldleider in de productie en verkoop van cosmetischehuidverzorgingsproducten, make ups, parfums en haarverzorgingsproducten.De Estée Lauder Oevel Site bestaat uit een fabriek, gespecialiseerd in tubes, liquids en lipsticks, een distributiecentrum, een coördinatiecentrum en enkele internationale diensten.Voor het distributiecentrum te Oevel zijn we op zoek naar een QC Analyst.Als QC Analyst sta je in voor de kwaliteitsgarantie van alle producten gestockeerd in, gedistribueerd door en geassembleerd door het Estée Lauder distributiecentrum.Verantwoordelijkheden Beheren van de stock status aangaande goederen binnen de distributie Uitvoeren van product sampling en rapporteren van resultaten Communiceren met de verschillende stakeholders, zowel regionaal als globaal, inzake onderzoek van (geretourneerde) producten Participeren in kleine projecten Vrijgave lite manufacturing producties in het distributiecentrum Behoud van quality mindset binnen operations, mede door uitvoeren van dagelijkse rondgangen, uitvoeren van inspecties Samenwerken met verschillende departementen (Operations, Business support, Inventory,.)Bedrijfsprofiel:Estée Lauder Companies werd opgericht in 1946.

Opvolgen van progress reports, werkuren onderaannemers etc..Regelen van alle elektrische voorzieningen en logistiek support voor onderaannemers (heftruck, cherry pickers etc).Als.Site Supervisor Constructie ben je.

Your duties can be divided into 3 aspects; project management - engineernig and quality control.

• On the one hand, you manage the project-related quality requirements.
• You supervise project changes made during the process at the customer's request.
• You resolve customer complaints about delivered goods.
• You prepare method statements and welding sequence plans.
• You prepare the production flow.
• You give kick-off meetings for the projects assigned to you.
• You work independently on continuous improvement projects.
• You support analysis/pre-study, transfer to production (first run and final acceptance) and after-care.
• You analyse production processes and make improvement proposals.
• You monitor the quality of incoming goods.
• You ensure that welders have the correct certification for a particular job and pass on additional tests if necessary.
• You follow up the results of ultrasonic and magnetic tests.
• You coordinate welding work in accordance with EN ISO 14731 : 2006.
• You draw up repair procedures.

Company:

Our client is an international company with a dynamic and international work environment where your initiative and contributions truly make a difference.You'll have the opportunity to work on remarkable projects in the offshore wind industry and civil sector, all within a thriving company group.

For their location in the Antwerp region, they are looking for a QC Engineer who also has knowledge of process engineering.

What does this job entail?

• Setting the price for the requested work.
• Preparing a clear offer in accordance with the request or specifications.
• Preparing the necessary documents for timely handover to colleagues in charge of execution.
• Maintaining contacts with suppliers and subcontractors.
• Monitoring quality issues (QA/QC).
• Preparing As built dossier.
• Supporting site management during execution where necessary.
• Contributing ideas on methods to perform the work more efficiently, ergonomically or at a higher quality level

Je bent verantwoordelijk voor het opgroeien van bacteriën en virussen;.Je voert steriliteitstesten en QC analyses uit op het eindproduct;.

For our client, we are looking for a Work Planner in the region of Antwerp to join the team.

The work mainly involves industrial civil construction projects.

What does this job entail?

• Setting the price for the requested work.
• Preparing a clear offer in accordance with the request or specifications.
• Preparing the necessary documents for timely handover to colleagues in charge of execution.
• Maintaining contacts with suppliers and subcontractors.
• Monitoring quality issues (QA/QC).
• Preparing As built dossier.
• Supporting site management during execution where necessary.
• Contributing ideas on methods to perform the work more efficiently, ergonomically or at a higher quality level.

Vanuit de verschillende Competence Centers (Engineering & Validatie; QA & QC; Maintenance & Operations en Operational Excellence & Project support) ondersteunt Select Projects nagenoeg alle vitale processen en activiteiten in de farmaceutische industrie, alsook in de cosmetica, biotechnologie en voeding..Bij Select Projects staat de ervaring die de klant heeft met onze medewerkers centraal.

Support the development of new products and reformulation of existing products, through the organization and execution of lab and plant trials, analytical and sensorial measurements and reporting.Key tasks:1.Organise tests (80%)Plan, design and execute lab, application, shelf life tests and sensory trials, in collaboration with the R&D manager2.

Hiervoor werk je nauw samen met customer support en het team in expeditie en je ondersteunt de Operations Manager bij alle taken van de toeleveringsketen (inbound – warehouse outbound).

When opportunities arise, get involved in Environmental Due Diligence, Environmental Compliance and Environmental Du Diligence.Mentor junior environmental employees of the Ramboll Belgium team..

Daarnaast waak je er mee over dat de wijzigingen tijdig worden geïmplementeerd zoals goedgekeurd door de bevoegde instanties.Het opstellen van regulatory change assessments en market allocation reports maken ook deel uit van je takenpakket.Je zal als QA Engineer verder ook verantwoordelijk zijn voor communicatie met andere sites en vertegenwoordigd jou site in product End 2 End meetings.

For our client in the region of Antwerp, we are looking for an Automation Engineer.

You will have a variety of responsibilities to maintain high quality standards of the dosing systems such as:

• Design, assemble, run, test and upgrade systems, best practices and processes to improve quality of output;
• Develop, configure and optimize industrial processes;
• Work with PLC-software;
• Perform process simulations, design calculations, Process Optimization;
• Select specific components for new installations;
• Develop and design P&ID’s, electrical schematics (SEE Electrical), user manuals and installation guides;
• Reparation of systems and/or components;
• Introduce and maintain Bill of Materials as necessary;
• Carry out quality control on goods, material, etc.;
• Report QC-problems;
• Interpret client requirements, identify and address design parameters and engineering problems;
• Assist Service & Support Manager at working out quotations;
• All the tasks mentioned in the System Procedures and the Internal Instructions of the quality system.

Responsibilities

• Schedule operators across multiple units within the CAR-T process operations, ensuring compliance with standard operating procedures and batch records.
• Collaborate closely with the CAR-T Operations Supervisor to discuss scheduling risks.
• Attend planning meetings to anticipate operational resource needs and communicate effectively with the CAR-T Operations Supervisor/Manager.
• Prepare long-term shift schedules well in advance.
• Schedule detailed shifts one week ahead and coordinate individual training sessions with the training department.
• Ensure that CAR-T Operator training aligns with job-specific tasks.
• Once trained, schedule operators to support and execute the CAR-T process according to procedures.
• Support tracking of training and qualification status of production personnel.
• Foster strong partnerships with the training department, supply chain planning, QC IPL, facilities & engineering, and maintenance.
• Ensure seamless execution of the training program as CAR-T process.
• Attend daily meetings within operations to ensure adherence to daily production tasks and compliance.

Company:

Role Overview The CAR-T Operations Resource Scheduler is a key position within the Technical Operations team.They are responsible for scheduling training and staffing for daily production of personalized cell therapy in a sterile c.GMP environment.This role operates in a team-based environment, adhering to assigned production shifts.



The company's Business Area Global Nuclear comprises 3 Business Streams and 4 Métiers covering services in several nuclear branches (Power Generation New Build, Power Generation Plant Operational Support, Power Generation Long Term Operations, Decommissioning and Dismantling, Medical,).Its Métier Civil Works and Infrastructure, with offices in Belgium (Brussels, Doel, Tihange), France (Gennevilliers, Lyon, Marseille & Tours) and the UK (Bristol) is seeking a Junior Civil Works Site Engineer to join the team in Doel..

Take care of quality documentation, provide training to employees regarding quality topics and support the sales department by analysis of customer specific requirements..Report to the Managing Director.

You prepare offers, negotiate sales contracts and provide technical support.You manage the distribution partners..

Inspecting the contractors execution activities, verifying compliance with execution drawings and documents (erection methodology, etc.);.Verifying and monitoring of QA/QC requirements;.Spent Fuel Storage Facilities)...

.analyze employer requirements, technical specifications, overall project planning, and resourcing..support the Construction department by providing technical information, inspection guidelines, and startup inspections for efficient commissioning .

Wat daar tegenover staat?.Select Projects biedt inhoudelijk interessante projecten, doorgroeimogelijkheden, autonomie, vertrouwen, opleidingen en vakkundige collega’s waar je van kunt leren.