21 jobs voor qc support gevonden

You even so explore new technologies to investigate potential future opportunities.You collaborate with engineering/operations in the development of new production methods and support them with upscaling new formulations and modifications of the raw material.You develop and validate new tests methods to monitor critical to quality (CTQ) parameters and assist Quality Control (QC) in setting up an effective QC program.You support QC in selecting, setting up, modifying, and validating complex lab equipment to meet projects needs.You coordinate lab technicians and technologists and train them in the proper use of the lab equipment.You use statistical techniques to estimate variability and utilize experimental design concepts to map results.You protect Intellectual Property (IP) of newly developed innovative solutions and perform intellectual property mapping for specific projects.You are part of the R&D department Sealants & Adhesives and report to the R&D Team leader.

Interesse ?We kijken graag uit naar je reactie via T 056/627611 of via waregem@unique.be JobomschrijvingUnique Office Waregem is op zoek naar een Operations support medewerker (m/v/x) voor een productiesite in Waregem..

Unique Office Waregem is op zoek naar een Operations support medewerker (m/v/x) voor een productiesite in Waregem..Het bedrijf zet in op het optimaliseren en digitaliseren van de processen binnen de operations afdeling, die bestaat uit productie, aankoop, logistiek, QC en technische dienst..

Building strong partnerships with Planning, Manufacturing & Process Technology, QC, Maintenance & Engineering, Facility & Utilities, Warehouse, and Quality..Acting as a Production Expert by training and coaching junior technicians, troubleshooting daily operational issues, and ensuring adherence to SOPs and safety practices..

Building strong partnerships with Planning, Manufacturing & Process Technology, QC, Maintenance & Engineering, Facility & Utilities, Warehouse, and Quality..Acting as a Production Expert by training and coaching junior technicians, troubleshooting daily operational issues, and ensuring adherence to SOPs and safety practices..

Management System SupportAls Management System Support draag je bij aan de realisatie van kwaliteitsdoelstellingen door het ondersteunen van projecten, audits, leveranciersbeheer en laboratoriumactiviteiten binnen ons management systeem en onze kwaliteitsafdeling.Jouw functieOndersteuning management systemen:Actieve en administratieve rol in het opzetten en verbeteren van processen en instructies gerelateerd aan QA/QC, ESG, Toy Safety, REACH, milieuwetgeving, security en het Cartamundi Management Systeem.Coördinatie en beheer van het interne auditsysteemCoördinatie en opvolging van actieplannenCoördinatie en opvolging van externe testen (met betrekking tot toy safety en milieuwetgeving)Update en beheer van procedures en instructiesOpzetten van communicatie en trainingen om de kennis van het management systeem te vergroten binnen de productieplantExterne audits:Assistentie bij ISO 9001 & 14001 audit, RBA audit, Ecovadis assessment en klantenauditsLeveranciersbeheer:Ondersteunen van de Supplier Quality Expert bij klachtenbeheer, procedures en audits bij leveranciers en onderaannemersLaboratoriumondersteuning:Ondersteunen van de Quality Technician bij het opstellen van meetplannen, uitvoeren van en rapporteren over labotesten op materialenAd hoc projecten gerelateerd aan kwaliteit:Deelname aan diverse project teams binnen en buiten de productieomgeving

• Perform quality tests for CAR-T cell therapy production within a controlled c.GMP cleanroom environment.
• Ensure that all tests are carried out according to applicable procedures, standards, and GMP regulations.
• Conduct analytical tests on raw materials, in-process samples, and final product samples.
• Document test results in electronic systems like LIMS.
• Draft, review, and approve relevant QC documents, SOPs, and work instructions.
• Manage daily production planning and support production investigations.
• Create and review SOPs, work instructions, master batch records, and forms.
• Ensure compliance with safety policies, quality systems, and c.GMP requirements.

Je geeft ondersteuning tijdens (klanten) audits en voert zelf ook interne audits uit..Je ondersteunt de kwaliteitsmanager in het up to date houden van het kwaliteits & HACCP systeem, het opleiden en coachen van (QC )medewerkers bij implementatie van nieuwe analysemethoden en/of apparatuur, het uitvoeren van traceerbaarheidsoefeningen..

Je geeft ondersteuning tijdens (klanten) audits en voert zelf ook interne audits uit..Je ondersteunt de kwaliteitsmanager in het up to date houden van het kwaliteits & HACCP systeem, het opleiden en coachen van (QC )medewerkers bij implementatie van nieuwe analysemethoden en/of apparatuur, het uitvoeren van traceerbaarheidsoefeningen..

Als Quality engineer ben je sleutelfiguur tussen productkwaliteit en het productieproces.Op basis van kritische analyses van klachten, trendings van non conformiteiten of opmerkingen uit audits, formuleer je verbetervoorstellen die je projectmatig verder uitwerkt.

Do you have a passion for technology and enjoy the challenge of keeping production lines running smoothly?At Agristo Nazareth, as a line supervisor, you will have the opportunity to independently manage two production lines, ensuring flawless operation, quality, and efficiency.

What will you be doing at Agristo?
You are responsible for independently managing 2 production lines.This includes, among other tasks:

• Starting the production line
• Adjusting the various machines within the line to achieve the desired product quality and efficiency
• Changing the line during product switches
• Cleaning machines during product switches
• Monitoring the proper functioning of each part of the line and making timely adjustments
• Checking that the correct raw materials are used
• Starting and stopping orders + using raw materials via our ERP system (SAP)
• Quality control in collaboration with the QC officer
• Solving small malfunctions on the line and assisting the technician during major breakdowns

Als Quality engineer ben je sleutelfiguur tussen productkwaliteit en het productieproces.Op basis van kritische analyses van klachten, trendings van non conformiteiten of opmerkingen uit audits, formuleer je verbetervoorstellen die je projectmatig verder uitwerkt.

The TMF Records Specialist is a member of the core trial team and is responsible to provide operational expertise to the core trial team, oversees the implementation of the (Trial Master File) TMF strategy for the trial and supports the core trial team in all aspects of TMF management and in inspections or audits.

The TMF Records Specialist provides and maintains oversight and guidance related to TMF activities throughout the course of the trial, to safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, ICH-GCP and applicable regulations and ensure inspection readiness at all times.

The TMF Records Specialist closely collaborates with the core trial team to create, implement and maintain the list of trial specific expected records.This includes the identification of all relevant trial level records required to reconstruct the trial, independent of owner or system hosting the record.

In this role you are responsible for the planning, tracking, formal QC and filing of all TMF trial level records according to internal and external standards and also to initiate the close out of the TMF.Besides you will share the status to the core trial team on the completeness, quality and timeliness of the TMF during the entire life cycle of the trial.

Manage quality systems, e.g.change control, deviations, and product investigations..P documentation review and on site visits..Distribute applicable documentation for Regulatory, Validation, and Subject Matter Expert review..

GMP areas..Coordinate and manage quality aspects related to production activities, including Change Control Requests, Deviations/events, and CAPA..

Lead and supervise various units within the process, such as component preparation, production support activities, process, filling & finishing, and cryopreservation..Build strong collaborative relationships with various departments, including Manufacturing Operations, QC IPC Operations, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Training, Planning, Procurement & Supply Chain/Warehouse..

Component preparation manufacturing, manufacturing support operations, CAR T process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to requirements.You will work in a team based, cross functional environment to complete production tasks required per schedule and drive continuous improvement of manufacturing operations leveraging own observation as well as input of junior team members.

Component preparation manufacturing, manufacturing support operations, process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to c.GMP requirements..

.Establish key stakeholder relationships with internal stakeholders (Manufacturing Operations, QC IPC Operations, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Planning).

Component preparation manufacturing, manufacturing support operations, process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to c.GMP requirements..

BRC, ACS, GMP+/FSA), external sustainability certification audits (incl.BIO/NOP, Fairtrade, Kosher, Halal, UTZ, Rainforest Alliance), inspections of authorities, customer audits and Puratos Group audits (e.g.