![MindCapture](https://media.trabajo.org/img/noimg.jpg)
Quality Specialist Gmp
il y a 1 semaine
QUALITY SPECIALIST GMP
- Biotechnology
- GhentWHAT IS OFFERED
This is a unique opportunity to have impact, write history and challenge yourself in a highly novel environment.
ABOUT THE COMPANY
MindCapture supports in the recruitment of this talent for a global biotech company that's developing, manufacturing and commercializing new cell-based therapies to battle cancer with focus on immunology.
The Quality Specialist GMP is an exempt level position with responsibilities for providing quality oversight over the production of a personalised cell therapy to support both clinical and commercial requirements in a sterile GMP environment.
- Serves as a quality specialist in plant in support of cell therapy manufacturing.
- Ensures quality oversight in plant covering various process related activities.
- Performs periodic quality checks/audits related to process, documentation and process manipulations.
- Strive to reduce nonconformances and deviations in supported areas by proactively driving compliance.
- Responsible for real time review of process documentation in support of process unit operations and release activities where needed.
- Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
- Supports in accurate and timely input, investigation and review of manufacturing deviations, CAPAs, change controls and complaints.
- Review and approve manufacturing procedures and batch records.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Support regulatory inspections and audits by ensuring inspection readiness within facility.
- Perform internal housekeeping audits.
- Bachelor's Degree in Science, Engineering or equivalent or relevant years of experience within the pharmaceutical industry
- 2 years relevant work experience is required, preferably within quality support in clinical manufacturing
- Knowledge of aseptic processing in ISO 5 clean room and biosafety cabinets
- Knowledge of GMP and FDA/EU regulations related to manufacturing of cellbased products
- Great attention to detail and structured/organised mindset to follow procedures
- Capable of working in a team environment with a positive attitude
- Experience with teambased collaborations
- Proactive
- Good written and verbal communication skills, ability to summarize and present results
- Problemsolving mindset
- Strong leadership skills to develop others and support
- Collaborate well with stakeholders (internal and external)
- Strong decisionmaking ability and think creatively while maintaining compliance and quality
- Ability to manage conflict and issues that arise with internal or external customers
- Working experience in an aseptic manufacturing facility is a plus
- Dutch and English
-
Lead Quality Training
il y a 2 semaines
Gent, Flandre, Belgique MindCapture Temps pleinLEAD QUALITY TRAINING Biotech GhentWHAT IS OFFEREDWe offer strong compensation packages that reward your abilities, hard work and ingenuity in achieving success.We reward you with competitive wages and offer a strong package with additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance. Depending on your...
-
Junior Quality Assurance Officer
il y a 2 semaines
Gent, Flandre, Belgique DeLaval Temps pleinThe Product Portfolio Milk Quality & Animal Health (PP MQAH) produces and distributes chemical products by, among others, the Chemicals Division in Drongen (Ghent). The Product Portfolio consists of udder hygiene products, hoof disinfectants and detergents used by dairy farmers around the world.We are currently looking for aJunior Quality Assurance Officer /...
-
Product Quality Manager
il y a 2 semaines
Gent, Flandre, Belgique Argenx Temps pleinAs part of the Product Quality organization, this function will drive operational quality assurance activities at key vendors for commercial biological drug products and plays a role in further build out of GMP quality infrastructure at argenx in close collaboration with internal business teams.ROLES AND RESPONSIBILITIES:In close collaboration with vendors,...
-
Product Quality Associate, IMP
il y a 1 semaine
Gent, Flandre, Belgique Argenx Temps pleinTo further strengthen our Quality team, we are looking for an experienced and motivated Product Quality Associate, IMP. The Product Quality Associate, IMP will play a role in further build out of GMP quality infrastructure at argenx in close collaboration with internal business teams and will be responsible to ensure the quality oversight of CMO's involved...
-
QA Document Control Specialist
il y a 1 semaine
Gent, Flandre, Belgique Legend Biotech EU Young Graduates Temps pleinAs a Quality Assurance Document Control Specialist, you are a cornerstone in our mission to save lives. Together with your colleagues from the Document Control Team, you monitor the integrity of our documents. You manage the document lifecycle, from creation to archiving, ensuring quality and compliance.What can you expect?In our GMP-controlled environment,...
-
QA Release Specialist
il y a 2 semaines
Gent, Flandre, Belgique MindCapture Temps pleinQA RELEASE SPECIALIST Biotech GentWHAT IS OFFEREDBe part of an international and diverse team, whilst developing one of the breakthrough innovations within healthcare and technology.This is a unique opportunity to have impact, write history and challenge yourself in a highly novel environment.ABOUT THE COMPANYMindCapture supports in the recruitment of this...
-
Senior Compliance Specialist Car-t
il y a 1 semaine
Gent, Flandre, Belgique Johnson & Johnson Temps pleinJanssen Pharmaceutica, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Compliance Specialist CAR-T. The position will be based in Ghent Belgium.CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient's own immune system. They are...
-
Process & Quality Specialist
il y a 2 semaines
Gent, Flandre, Belgique Oxida Temps plein**Functie**- Je bepaalt de kwaliteitsnormen, methodes en procedures in samenspraak met het team teneinde de huidige kwaliteitssystemen verder te optimaliseren.- Je voert de nodige technische kwaliteitscontroles uit op zowel grondstoffen als afgewerkte producten en zorgt voor een correcte rapportage van de resultaten.- Je bent mee verantwoordelijk voor de...
-
Quality Assurance Manager Belgium
il y a 2 semaines
Gent, Flandre, Belgique BIVMB Temps pleinTHE OPPORTUNITY - DO WORK THAT MATTERSWe are seeking a highly motivated Quality professional with GMP expertise to join us as the new Quality Assurance Manager at Boehringer Ingelheim Veterinary Medicine Belgium. At BIVMB we focus on the equine mesenchymal stem cells platform, addressing the unmet needs of multiple veterinary patients.In this exciting role,...
-
Quality Officer
il y a 2 semaines
Gent, Flandre, Belgique Nuwhï Temps pleinFor a leading consulting company, known for its quality and reliability, we are looking for consultants who want to deepen their knowledge in different areas of expertise. With a strong customer focus, the team provides professional and specialized advice and services to the pharmaceutical industry both nationally and internationally.The main services are in...
-
Quality Assurance Manager
il y a 2 semaines
Gent, Flandre, Belgique Securex Temps plein**Groupe SCX**Depuis plus de 115 ans, Securex aide ses clients et ses employés à briller dans leur vie professionnelle. Chaque jour, nos 1 700 collègues s'engagent à soutenir les entrepreneurs et les employeurs dans leurs activités professionnelles.Nous offrons à ces entrepreneurs et employeurs la gamme de services la plus étendue du marché: guichet...
-
Regulatory Affairs Specialist
il y a 1 semaine
Gent, Flandre, Belgique Jefferson Wells Temps pleinLocation:**Gent****#23587****Regulatory Affairs Specialist**Vast Contract - Regio Gent**#regulatory #affairs #specialist #food**Beschik je over een masterdiploma met een voorkeur voor een specialisatie in landbouw, voeding of chemie? Heb je min. 3 jaar ervaring in Regulatory Affairs? Ben je zelfstandig, zeer communicatief en computervaardig? Lees dan vooral...
-
Warehouse Operator with Gmp Experience
il y a 2 semaines
Gent, Flandre, Belgique Page Personnel Temps pleinadded 15/03/202Logistics and supply chain Biotechnology leaderAbout Our Client:The company is a worldwide expert in biotechnology and is constantly looking for new medical solutions to increase people's health.The function is varied with the following responsibilities:Receive goods Package finished product for shipping and prepare for loading Unload raw...
-
Qms Specialist
il y a 2 semaines
Gent, Flandre, Belgique Legend Biotech EU Temps pleinCompany InformationLegend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.Position OverviewThe QMS Specialist will provide...
-
Qc Investigation Specialist
il y a 2 semaines
Gent, Flandre, Belgique Legend Biotech EU Temps pleinCompany InformationLegend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.Role OverviewThe QC Investigation Specialist,...
-
Interim Quality Manager
il y a 2 semaines
Gent, Flandre, Belgique elekti. Temps plein**Interim Quality Manager.**:**De functie**:De functie gebonden verantwoordelijkheden zijn:- Implementeren, onderhouden en bijsturen van het kwaliteitszorgsysteem zodat wordt voldaan aan de normen voor ACS (voedselveiligheid), IFS en het intern bedrijfskwaliteitsniveau.- Verantwoordelijke voor de efficiënte werking van het eigen labo zodat de nodige...
-
Specialist verpakking
il y a 1 mois
Gent, Flandre, Belgique Randstad Temps pleinLogistics Specialist PackagingAs a Logistics Specialist Packaging, your main tasks include:Organizing logistical operations of packaging material for spare parts in Europe within the Spare Parts Quality department in Ghent.Daily monitoring of the order process and inventory management of packaging material.Ensuring the rotation of reusable packaging for...
-
Specialist verpakking
il y a 4 semaines
Gent, Flandre, Belgique Randstad Temps pleinLogistics Specialist PackagingAs a Logistics Specialist Packaging, your main tasks include:Organizing logistical operations of packaging material for spare parts in Europe within the Spare Parts Quality department in Ghent.Daily monitoring of the order process and inventory management of packaging material.Ensuring the rotation of reusable packaging for...
-
Product Specialist
il y a 2 semaines
Gent, Flandre, Belgique DeLaval Temps pleinDeLaval is looking for aProduct Specialist to join the 'Milk Quality and Animal Health' team. This team is responsible for part of DeLaval aftermarket products. Drives innovation and manages cleaning solutions and udder health solutions. As product specialist you will have an important role in supporting product managers in providing our customers with new...
-
Sr. Director, Site Quality Head, Ghent Cell Therapy
il y a 2 semaines
Gent, Flandre, Belgique Johnson & Johnson Temps pleinFor more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.We know that the success of our business depends on having the best talent in a workforce that reflects the...