41 jobs voor quality assurance support gevonden

Als Quality Assurance Support bestaat je takenpakket uit volgende:...Je rapporteert aan de Quality Manager.Bedrijfsprofiel:Voor onze klant, marktleider in de farmaceutische en chemische sector, is Select op zoek naar een quality assurance support.

.As a Supplier Assurance Manager, you will develop Quality, Food Safety, Sustainability & Ethical compliance strategy for external purchased products (Europe and North America).

For our production site in Groot-Bijgaarden, we are looking for a vendor quality assurance engineer to support our Quality team.

Are you looking for a position where you can take the lead in the quality assurance process for our vendors and assure food safety for our clients?Do you love collaborating with internal and external stakeholders and do you like to put your problem solving skills to good use?Then this might be your next job!

Key Accountabilities

* You take the lead in the coordination of the vendor quality assurance process for our manufacturing plant in Groot-Bijgaarden.

* You take the lead in the development and maintenance of the Raw Material Monitoring plan.

* You assist the QC Manager, Purchasing and other departments in using the results of the Raw Material Risk Analysis in inspection plans and supplier agreements.

* You assist the Quality Manager in managing Raw Material related crisis's.

* You schedule and perform audits at relevant suppliers and copackers.

* You coordinate and manage vendor quality complaints.

* You create awareness on vendor quality.

* You guarantee the compliance with applicable laws and international standards regarding food safety: safety, working conditions, Hazard Analysis and Critical Control Points (HACCP), Prerequisite Programs (PRP), British Retail Consortium (BRC), Food and Drug Administration (FDA), Halal, Kosher, allergens,

Als grootste Europese private label producent van rijst , maïs en meergranenwafels levert Sanorice hun producten aan A merken, retailers en distributeurs in meer dan 40 landen.Ter versterking van hun Quality Team zoeken wij een Quality Assurance Spupport met zin voor verantwoordelijkheid .

Wil jij de kwaliteitsdienst van een pharmaceutisch bedrijf administratief ondersteunen ?

Als Quality Assurance Support bestaat je takenpakket uit volgende:

- Administratieve ondersteuning aan de afdeling kwaliteit en er mee over waken dat het

kwaliteitsbeheersysteem wordt gehandhaafd

- Het vrijgeven van producten, alsook onderhouden van het vrijgaveregister

- Opmaken van maandelijkse registers en rapportering voor narcotica, psychotropen en

precursoren

- Je staat mee in voor het up-to-date houden van het elektronisch documentatie- en

trainingssysteem alsook het uitschrijven van GDP-gerelateerde procedures en het opvolgen van

trainingen.

- Ook uitvoeren van zelfinspecties en audits volgens een vooraf opgesteld schema en

bijkomend de nodige corrigerende maatregelen treffen

- Behandelen van retour-producten

- Instaan voor onderhoud registratiedossiers volgens wetgeving

- Evalueren en goedkeuren van productspecificaties en etiketmasters.

- Adviseren en faciliteren van de marketing afdeling bij productlanceringen op vlak van kwaliteit

- Je rapporteert aan de Quality Manager.

Bedrijfsprofiel:

Dit bedrijf is gespecialiseerd in distributie van medische producten.

Ligt in een industriezone, dus geen parkeerproblemen.

Je komt in een mooie en aangename werkomgeving terecht.

We are looking for a Product assurance engineer for Space Development!

• You are responsible for failure-proofing missions by ensuring that materials, mechanical parts, processes and electrical components used to assemble a space product shall be fit for purpose over the entire life of the mission.

• You are the counterpart for customer and subco PA’s.
  
• You support configuration control & data management.
  
• You manage PA & Safety requirements and Prepare PA plan.
  
• You are responsible for the creation & maintenance of all required PA templates, forms & databases.
  
• You take care of the cleanliness & Contamination control.
  
• You support design & procurement process (selection, audits, specifications).
  
• You are responsible for PMP and EEE selection and documentation.
  
• You organize, manage & lead PA related meetings & inspections.
  
• You follow up non-conformance & waiver/deviation control.

Thorough technical knowledge and interest, in product knowledge, chemical paint assembly process knowledge and quality systems.Well developed analytical skills.

Je neemt de lead in de PQM (product quality meetings samen met technical customer support, R&D, production engineering,) en werkt kwaliteitsprocedures en verbeterprocessen uit, past ze aan en volgt de correcte toepassing op..Je zet kwaliteitsprocedures op voor nieuwe machines..

Your main tasks and responsibilities:

• Launch and follow-up of modified series productions (change in design by customer or internal changes and improvements from Production, WCM team, Logistics, Quality,)
• You follow up and coordinate the first production run (APQP) of the modified parts in cooperation with the Project Engineer, QA (Quality Assurance) , Production and Logistics.
• You communicate internally with your direct colleagues as well as with your colleagues from other departments.You communicate externally with your suppliers and if applicable with your customer.
• Planning and follow-up of the production launch
• Follow-up of the prototypes on the shop floor at the start-up of the various process steps (bending-seaming-final forming-welding.)
• Handling technical problems at start-up with other team members of the quality and logistics department
• You perform post-calculation on the first production runs and, where possible, implement improvements.
• You may be appointed to start up old Spare Parts in production, for which an alternative flow must be worked out.For this, you also take care of the follow-up.
• You may be appointed to investigate the resulting dead stock
• You can be appointed to follow up and support improvement projects.

Wij zijn op zoek naar een enthousiaste QA Specialist voor de Productieafdeling van een farmaceutisch bedrijf.In deze rol ben jij een cruciaal element bij het waarborgen van kwaliteit binnen onze faciliteit.Je verantwoordelijkheden omvatten het opvolgen van batch records, implementeren van real-time exception review en ondersteuning bieden aan het 24/7 QA-team.Samenwerking, GMP-support en proactieve deviatiepreventie maken integraal deel uit van deze dynamische positie.

Verantwoordelijkheden:

• Beoordelen en nauwlettend volgen van master batch records en EBR's.
• Actief opvolgen, beoordelen (en behandelen) van QA-events en batch records.
• Bieden van ondersteuning aan het 24/7 QA-team, zowel in hun dagelijkse werkzaamheden als bij het overzien van taken gedurende verschillende ploegen.
• on-the-floor GMP-support, inclusief het uitvoeren van GEMBA-rondes.
• Faciliteren van samenwerking tussen verschillende afdelingen.
• Evalueren en opvolgen van declassificaties, inclusief de implementatie en monitoring van vernieuwde werkwijzen.
• Opvolgen van de QA-review van werkorders.
• Identificeren van het juiste moment om problemen/QA-events op te schalen naar de supervisor/manager.

.You support the planning and execution of internal and external quality audits...You ensure efficient administration about all quality issues.

Daarbij horen ook klanten en leveranciers waarvoor je ook audits organiseert.Tevens neem je de leiding in de product quality meetings samen met de andere afdelingen (R&D, support, productie) en werk je kwaliteitsprocedures en verbeterprocessen uit.

Quality Assurance: Adhere to internal procedures, document diligently, and participate in verification and technical reviews to ensure high quality outputs .Team Collaboration: Communicate effectively, share knowledge, contribute to team success, and partake in team events .

Om de groeiplannen in Benelux te ondersteunen zijn we opzoek naar een gepassioneerde Quality Assurance & Regulatory Officer: Health, Personal Care & Pharma (HPC).Binnen deze brede functie krijg je de mogelijkheid om de kwaliteit te waarborgen voor producten en diensten die door worden geleverd.Dit met focus op de diensten van HPC afdeling (Health, Personal Care & Pharma).

Jouw uitdaging:

• Je volgt projecten voor de HPC klanten op en zorgt zo voor de ontwikkeling en opvolging van “longterm-relationships”
• Ondersteunen van cleanroom validatie projecten t.b.v.(nieuwe) klanten of (nieuwe) producties.
• Je volgt vragen van klant op.
• Je begeleid klanten audits en/of zorgt voor een plan van aanpak.
• Updaten van regulatory information sheets (RIS) in het ERP pakket (Confluence).
• Je zorgt voor de nodige support bij audits zoals GDP-API & ISO-9001 audit.
• Je volgt de volledige klachtenflow van HPC klanten op.
• Organiseren van interne audits om het kwaliteitsniveau binnen de organisatie verder te verhogen.
• Je stelt quality agreements met zowel leveranciers als klanten op en zorgt voor het nodige onderhoud hiervan
• Opvolging resultaten van stalen die uitgezet worden bij externe labo’s.
• Proces certificaten of analysis opvolgen en verbeteren.

For a major medical company specialised in clinical research we are looking for a Logistics Coordinator Quality & Special Projects officer.You’ll be arranging all supply chain and transportation administration on all researched and yet to be researched samples.On top of that you’ll be responsible for all quality and compliance investigation.

Logistic Tasks:

• Tracking and tracing the packages from the laboratories to clients and backwards
• Contacting companies for transportation to be arranged
• Helping the Supply chain department
• Monthly reports
• Arranging shipments between the different laboratories around the globe

Quality Tasks:

• Events and CAPA management
• Providing training, retraining and new process improvements
• Analyse needs of directors an Standard Operation Procedures
• Support site services by improving work methods
• Point of contact for the Quality assurance teams and all site services

The activities delivered by the Workplace teams are covering the following solutions: Physical and virtual workstations, Software packaging and licensing, Workforce Collaboration solutions (Office 365,…), Telephony Services and Secure Data Exchange.Moreover the Service Desk activities (Level 1 and Level 2) are also included in the scope of the Workplace team.We are currently seeking to reinforce the team by appointing a Service Delivery Manager.Your responsibilities as Service Delivery Manager: You closely supervise the IT end user support outsourced service contract in place for AXA Belgium and assure that the service delivered is in line with agreed SLA's.You actively participate in the governances in place with the different partnersYou are owner of the continuous improvement process and definition of priorities in close alignment with Quality Assurance team and Business needsYou define and coordinate the implementation of Continuous Improvement plans together with Service Management teams and with business and IT product teams cross domainsYou are in charge of monitoring the quality of the Workplace services including the overall employee satisfaction, together with the operational KPI's for processes in scope of responsibilityYou contribute to Qo.

.Let’s talk about youMaster in a relevant field like business, economics or engineeringAt least 5 years of relevant experienceStrategic mindset and fascinated by new technologies, intellectually curious and eager to challenge existing paradigmsHands on, result oriented and quality drivenKeen on daily interaction and close collaboration with the clientStrong communicator and team player, but can also work independently

As an Intelligent Solution Architect, you're not just a designer; you're the driving force that oversees projects, maintains quality, and provides expertise in blueprints and quotes.Your role extends beyond design, encompassing QA, development guidelines, best practices, and project management in some cases..

Je biedt technische training aan klanten (nutritie) + support aan het sales team.Je beheert het contact met FAVV (Audits, support health certificates…).

As Electrical Package Engineer, you will:

• Provide technical High Voltage support to the electrical package team
• Assist in the design process, supplier selection process andfabrication and installation phase of the offshore and onshore substation and HV/MV cables
• Identify and check the technical and contractual interfaces between substation contracts, cable supply contracts and installation contracts
• Ensure that relevant HSE requirements are satisfied for the different contracts
• Assist in the technical part of the Employer Requirements process
• Report to the Electrical Package Manager.
  

Furthermore, during the construction phases of our projects you will follow up fabrication and construction works in the factories and the pre-assembly and construction sites.

Tasks and Responsibilities:

• Predesign of basic electrical HV infrastructure and SLD for operating an offshore windfarm
• Define and calculate the major components of which the electrical infrastructure of a windfarm is composed of: HV and MV cable sections, HV transformers, shunt reactors,…
• Participate in the design review with contractors of the proposed overall electrical infrastructure for an offshore wind farm
• Follow up the different tenders issued for the Electrical Infrastructure
• Review the contractor's assumptions and documents to assure a feasible design as well as a design that meets the Parkwind requirements on availability and maintainability
• Check the proposed electrical design in respect to the grid requirements of the TSO, the Parkwind Employer Requirements and interface descriptions
• Assist in discussions with TSO/Contractor regarding grid compliance requirements, the design of the reactive power compensation and implementation
• During production phase check quality assurance and product specification of cables produced
• Monitoring of production schedules
• Witnessing of the factory acceptance tests (FAT)
• Overall inspection of the quality plan of the manufacturer and the production records (internal checks, deviations and routine tests)
• Build up knowledge on the applicable IEC standards and the critical items during FAT of cables
• During the onshore and offshore installation phase of the wind farm follow up and check the necessary quality assurance and control related to the offshore substation commissioning and cable installations
• Interface coordination and management between the different scopes and parties such as the Supply and Installation Contractor of the export cable and infield cables and OHVS contractor
• Evaluation of transport plans and provisions
• Quality and HSE control on onshore cable installation and jointing procedures and workmanship
• Interface coordination TSO – Contractor on HV connection, protection settings, information exchange and reactive power compensation
• Evaluation of commissioning and test plans
  

Flexibility (in both directions) will be a large part of your function.Primarily you will be based in our offices in Leuven.You will have the opportunity to perform offshore visits and occasionally you will have to travel, both in Europe and overseas.

As Electrical Package Engineer, you will:

• Provide technical High Voltage support to the electrical package team
• Assist in the design process, supplier selection process andfabrication and installation phase of the offshore and onshore substation and HV/MV cables
• Identify and check the technical and contractual interfaces between substation contracts, cable supply contracts and installation contracts
• Ensure that relevant HSE requirements are satisfied for the different contracts
• Assist in the technical part of the Employer Requirements process
• Report to the Electrical Package Manager.
  

Furthermore, during the construction phases of our projects you will follow up fabrication and construction works in the factories and the pre-assembly and construction sites.

Tasks and Responsibilities:

• Predesign of basic electrical HV infrastructure and SLD for operating an offshore windfarm
• Define and calculate the major components of which the electrical infrastructure of a windfarm is composed of: HV and MV cable sections, HV transformers, shunt reactors,…
• Participate in the design review with contractors of the proposed overall electrical infrastructure for an offshore wind farm
• Follow up the different tenders issued for the Electrical Infrastructure
• Review the contractor's assumptions and documents to assure a feasible design as well as a design that meets the Parkwind requirements on availability and maintainability
• Check the proposed electrical design in respect to the grid requirements of the TSO, the Parkwind Employer Requirements and interface descriptions
• Assist in discussions with TSO/Contractor regarding grid compliance requirements, the design of the reactive power compensation and implementation
• During production phase check quality assurance and product specification of cables produced
• Monitoring of production schedules
• Witnessing of the factory acceptance tests (FAT)
• Overall inspection of the quality plan of the manufacturer and the production records (internal checks, deviations and routine tests)
• Build up knowledge on the applicable IEC standards and the critical items during FAT of cables
• During the onshore and offshore installation phase of the wind farm follow up and check the necessary quality assurance and control related to the offshore substation commissioning and cable installations
• Interface coordination and management between the different scopes and parties such as the Supply and Installation Contractor of the export cable and infield cables and OHVS contractor
• Evaluation of transport plans and provisions
• Quality and HSE control on onshore cable installation and jointing procedures and workmanship
• Interface coordination TSO – Contractor on HV connection, protection settings, information exchange and reactive power compensation
• Evaluation of commissioning and test plans
  

Flexibility (in both directions) will be a large part of your function.Primarily you will be based in our offices in Leuven.You will have the opportunity to perform offshore visits and occasionally you will have to travel, both in Europe and overseas.

QUALITY

• Deputy Qualified Person for batch certification according to the Directive 2001/83/EC on medicinal products for human use and the guidelines on Good Manufacturing Practices (GMP) (Volume 4).
• Deputy RP for Good Distribution Practices (GDP) according to the Directive 2001/83/EC on medicinal products for human use and the guidelines of 5 November 2013 on GDP for medicinal products for human use.
• Review, compilation and release of batch records for administrative (GDP) release or batch certification (GMP), as appropriate.
• Completion of register of released batches (and samples).
• Quality oversight of contracted out manufacturing operations.
• Assist in the management of the distribution including import and export of medicines.
• Review and approval of transfer and validations of manufacturing and testing operations.
• Lead the drafting/approval of product specifications.
• Assist in the preparation of the quality management review at group level.
• Proactively participate as a senior quality team member in the company's QMS processes, including but not limited to deviation/investigation management, corrective and preventative actions, change control and complaints management.
• Ensure compliance with marketing authorisations / CE mark (regulatory dossier).
• Assist in the management/coordination of all activities related to a batch recall
• Proactively participate in the management of artwork and marketing/promotional materials.
• Assist in the management of stability studies and Product Quality Review.
• Ensure the compliant implementation of serialization.
• Audits & Inspections:
  • Participate in the preparation and risk assessments for the internal and external audit schedules.
  • Plan and lead external audits.
  • Participate in inspections by competent authorities as a subject matter expert.
  • Participate in self-inspections / internal audits.

Other

• Assist in local aspects of Regulatory Affairs
• Assist the Medical and Vigilance (Pharmaco and Materiovigilance) department to ensure compliance at SERB SA.
• Assist in the management of medical / scientific information requests.
• Assist in the management of advertising, samples, compliance in relation to the RP function for Belgium, Luxembourg and the Netherlands.
• Assist in the management of prices and refunds for Belgium, Luxembourg and the Netherlands.
• Monitors the regulations in force and their evolution.
• Assist for budget management.

Team management

• This role does not have reporting staff, but is expected to work within the matrix of the local (SERB SA) and wider (SERB Pharmaceuticals) quality teams as a senior member.This will include providing support, training and mentoring to the more junior members of the team as required for team development and efficient and compliant performance of the team.

QUALITY

• Deputy Qualified Person for batch certification according to the Directive 2001/83/EC on medicinal products for human use and the guidelines on Good Manufacturing Practices (GMP) (Volume 4).
• Deputy RP for Good Distribution Practices (GDP) according to the Directive 2001/83/EC on medicinal products for human use and the guidelines of 5 November 2013 on GDP for medicinal products for human use.
• Review, compilation and release of batch records for administrative (GDP) release or batch certification (GMP), as appropriate.
• Completion of register of released batches (and samples).
• Quality oversight of contracted out manufacturing operations.
• Assist in the management of the distribution including import and export of medicines.
• Review and approval of transfer and validations of manufacturing and testing operations.
• Lead the drafting/approval of product specifications.
• Assist in the preparation of the quality management review at group level.
• Proactively participate as a senior quality team member in the company's QMS processes, including but not limited to deviation/investigation management, corrective and preventative actions, change control and complaints management.
• Ensure compliance with marketing authorisations / CE mark (regulatory dossier).
• Assist in the management/coordination of all activities related to a batch recall
• Proactively participate in the management of artwork and marketing/promotional materials.
• Assist in the management of stability studies and Product Quality Review.
• Ensure the compliant implementation of serialization.
• Audits & Inspections:
  • Participate in the preparation and risk assessments for the internal and external audit schedules.
  • Plan and lead external audits.
  • Participate in inspections by competent authorities as a subject matter expert.
  • Participate in self-inspections / internal audits.

Other

• Assist in local aspects of Regulatory Affairs
• Assist the Medical and Vigilance (Pharmaco and Materiovigilance) department to ensure compliance at SERB SA.
• Assist in the management of medical / scientific information requests.
• Assist in the management of advertising, samples, compliance in relation to the RP function for Belgium, Luxembourg and the Netherlands.
• Assist in the management of prices and refunds for Belgium, Luxembourg and the Netherlands.
• Monitors the regulations in force and their evolution.
• Assist for budget management.

Team management

• This role does not have reporting staff, but is expected to work within the matrix of the local (SERB SA) and wider (SERB Pharmaceuticals) quality teams as a senior member.This will include providing support, training and mentoring to the more junior members of the team as required for team development and efficient and compliant performance of the team.

Our services continue to expand, with the introduction of new laboratory capabilities in all our global laboratories.µµMedpace Reference Laboratories is a full service central clinical trial laboratory offering project management, laboratory services, data management, logistics, and sample management and archiving capabilities, and quality assurance.. .

.Adhere to the design, documentation, development, quality assurance, security control and support processes of the Agfa tools..Experience with virtualization technologies, cloud computing and cloud services (AWS, Azure, Swift) .

.Maintaining production areas, following procedures to produce clinical & commercial grade ATMPs, and testing batch samples for quality assurance.fixing equipment issues, improving processes, and introducing new products..

.Maintaining production areas, following procedures to produce clinical & commercial grade ATMPs, and testing batch samples for quality assurance.fixing equipment issues, improving processes, and introducing new products..

Our private label customers include strong brands, importers active within supermarket chains, foodservice, bakery distribution, and industrial food production..