22 jobs voor qc support gevonden

.Understand and document customer needs to ensure product alignment with customer requirements.

Lead customer complaints, production nonconformities and CAPA investigations to support continuous improvement.

Lead root cause investigations and search for effective solutions within a multidisciplinary team to resolve production issues.

Support the Management Review Board to ensure rejected products are properly disposed, risks are mitigated and support production continuity.

Handle technical customer requests and secure proper introduction into production.

Participate in a cross-functional team to reduce risks related to the manufacturing process through p.FMEA review.

Contribute to the validation of manufacturing processes.

Contribute to the continuous improvements of quality processes by identifying and leading improvement projects.

Support customer audits.

Provide support to the QC department regarding customer specifications and inspection methods.

Lead improvement projects for inspection equipment and methods.

Contribute to compliancy with ISO 13485, AS 9100 and FDA QSR standards.

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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.

.Vous êtes en charge des analyses physico chimiques (IR, KF,) et chromatographiques (HPLC, GC) en support à la production ; .

Opvolgen en reviewen van general project documentation (risk assessments, validatie plannen, procedures, batch records,)..Quality ondersteuning en expertise delen m.b.t.

Operational : Develop and validate analytical methods to support projects in development in different phases of product development.Perform analyses of raw materials, intermediate products, in bulk or pakaged finished products in accordance with work instructions and established procedures (stabilities, in process control, clinical release, investigation,).

• 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.

Conduct design reviews, troubleshooting investigations, and provide machine troubleshooting support to end users, ensuring efficiency and smooth workflow..Integrate latest developments into current roadmap, establish technical documentation, training materials, and troubleshooting guides for newly automated processes..

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..

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).

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.

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.

You will lead and perform multiple units within the CAR T process operations (i.e.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.

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.

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, 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..

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).

Your Mission

In the heart of Puratos' R&D site in Andenne, you oversee Downstream Processing (DSP) projects, dedicated to the recovery of valuable proteins and enzymes post-fermentation.Your role extends to scaling up laboratory processes to industrial plant standards, emphasizing meticulous analysis and downstream procedures.Collaborating closely with the bioprocess manager, you lead the charge in driving process and technological improvements, ensuring efficiency and innovation.Additionally, you provide crucial support for the seamless transfer of technology into manufacturing or quality control, spearheading impactful technology transfer programs.

What you will do

- You will be exploring and innovating new DSP to enhance Puratos' processes for enzyme and protein recovery after fermentation, encompassing techniques such as MF, UF, chromatography, and sterile filtration.

- You will be responsible for the design and spearheading process development, characterization, scale-up (from benchtop to pilot unit), and tech transfer to onsite manufacturing facilities, all based in Andenne.

- You will have the chance to share your expertise and coach and mentor junior team members, offering guidance in downstream processing.

- You will apply bioengineering principles for troubleshooting, process modeling, and experimental design and execution.

- Under your supervision corrective actions and control plans to minimize variability and boost productivity in Downstream performance will be implemented.

- You will be collaborating and sharing expertise with cross-functional departments including QC, production, and regulatory teams.

- It is important to present updated results internally and potentially externally during meetings.

- You will be identifying, proposing, and executing analytical protocols for evaluating yields and recovery when necessary.

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.

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.