QA Operations Specialist
il y a 2 semaines
Exothera is a contract development and manufacturing organization (
CDMO) dedicated to virus and viral vector production.
As a Univercells company,
Exothera provides best-in-class bioprocessing expertise that capitalizes on novel manufacturing technologies. The company delivers accelerated process development/optimization to rapidly reach GMP clinical and commercial production of virus and viral vectors. At
Exothera and
Univercells, our mission is to make health equally accessible to all.
Based in Jumet you will join a
QA Operations team and you will contribute to the start-up and operation of our brand new Exothera pharmaceutical manufacturing site for viral vectors.
As
QA Operations Specialist you will be part of the QA department and you will provide the link between the manufacturing operations and the quality system to safeguard the quality, safety, and efficacy of pharmaceutical products and the cGMP conditions of the manufacturing processes and area.
RESPONSIBILITIES
In relation to the Quality system you will:
- Provide on the floor QA support by advising and counseling on cGMP and related quality assurance issues to the value stream
- Establish, implement, maintain and continuously improve QA Operations documents and documentation
- Initiate, participate, document, review, and approve operational risk assessments
- Take initiative to resolve deviation and OOS situations, participate in related investigations and review and approve related reports
- Review and approve change requests, related actions plans, and documentation
- Participate and provide training of personnel in relation to quality and cGMP requirements, both in classroom and shopfloor environment
- Perform annual product review activities
- Participate in selfaudits, customer audits, and health authority inspections
In relation to the Production System you will:
- Review and approve operational cGMP documentation for completeness and compliance to cGMPs in line with regulatory requirements and internal procedures
- Issue and oversee the appropriate use of batch records
- Examines and evaluates production documentation, including batch records, inprocess results, and other relevant production documentation; advice the Qualified Person on potential quality issues and disposition decision
In relation to the Materials System you will:
- Review and approve incoming materials documentation
- Release of incoming materials upon review of documentation
REQUIREMENTS / QUALIFICATIONS
We are looking for new colleagues with these required skills to support our ambitious goals:
- MSc or equivalent in a scientific discipline, engineering, or related discipline with the required skills, knowledge, and abilities that are typically acquired through experience in a biopharmaceutical manufacturing environment with cell culture activities.
- 5 years of hands-on GMP experience in pharmaceutical QA, QC, MS&T, or sterile manufacturing environment
- Experience with singleuse processes and equipment
- Experience or are highly interested in digital QA approach
- Moreover, you possess excellent problem solving (and master quality investigation techniques) You get energized by Teamwork
- You are able to define pragmatic solutions within the pharmaceutical regulatory framework
- You are fluent in French and English (both oral and written)
-
QA Specialist Release
il y a 1 semaine
Charleroi, Wallonie, Belgique UNIVERCELLS Temps pleinAt Univercells, we are on a mission to make health equally accessible to all. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: biologics for allExothera, a Univercells affiliate, is a Contract Research, Development, and Manufacturing...
-
QA System Specialist
il y a 2 semaines
Charleroi, Wallonie, Belgique UNIVERCELLS Temps plein_Exothera_:- is a contract research, development, and manufacturing organization (__CRDMO_:- ) dedicated to viral vector and nucleic acids production. As a technology-driven company, __Exothera_:- provides best-in-class bioprocessing expertise that capitalizes on the best and most innovative manufacturing technologies developed within the __Univercells...
-
CSV Specialist
il y a 2 semaines
Charleroi, Wallonie, Belgique Akkodis Temps pleinDescription du poste Métier OPERATIONS - CONSULTING Intitulé du poste CSV Specialist Contrat CDI Description de la mission Contexte Pour plusieurs de nos clients, nous sommes à la recherche de profile CSV pour l'industrie pharmaceutique (Charleroi, Braine l'alleud et Wavre). Votre role en tant que CSV : Piloter les activités...
-
Technicien QA en production cellulaire
il y a 2 semaines
Charleroi, Wallonie, Belgique Start People Pharma Temps pleinDescription En tant que Technicien QA en production cellulaire, vous jouerez un rôle essentiel dans l'exécution des activités de terrain, en respectant strictement les normes GMP. Vous serez responsable de superviser et de participer aux opérations de production, en garantissant la conformité aux procédures et aux réglementations en vigueur.En...
-
Gcp QA Director
il y a 2 semaines
Charleroi, Wallonie, Belgique Hobson Prior Temps pleinSalary:NegotiableJob type:Interim/ContractLocation:Charleroi, BelgiëFunction:Quality Assurance, Quality SystemsPosted:05/03/2024Ref:BBBH2431- Hi I'mFrankie, I manage this roleHobson Prior are currently looking for a GCP QA Director to join a brilliant pharmaceutical organisation on a contract basis located in Gosselies. Our client is focused on pioneering...
-
Quality Assurance
il y a 2 semaines
Charleroi, Wallonie, Belgique Akkodis Temps pleinDescription du poste Métier OPERATIONS - CONSULTING Intitulé du poste Quality Assurance & CSV Specialist - Life Sciences Contrat CDI Description de la mission Dans le cadre de la croissance de nos activités dans le secteur Life Sciences francophones, nous sommes à la recherche d'un profil QA & CSV Engineer. Description du poste: ...
-
Quality Assurance Systems Specialist- Exothera
il y a 2 semaines
Charleroi, Wallonie, Belgique UNIVERCELLS Temps plein_Exothera_:- is a contract research, development, and manufacturing organization (__CRDMO_:- ) dedicated to viral vector and nucleic acids production. As a technology-driven company, __Exothera_:- provides best-in-class bioprocessing expertise that capitalizes on the best and most innovative manufacturing technologies developed within the __Univercells...
-
Opérateur de Production
il y a 2 semaines
Charleroi, Wallonie, Belgique Unique Temps plein**Description**:Nous cherchons un opérateur de production (h/f/x) pour renforcer l'équipe de notre client.Vos tâches en tant qu'opérateur de production (h/f/x):- Veiller à la réalisation de test de faisabilité de composition- Veiller à la réalisation sous forme de batch d'élément de construction (blocs, pavés, briquettes, etc )- Veiller à la...
-
Opérateur Pelle Excavatrice
il y a 2 semaines
Charleroi, Wallonie, Belgique Accent Temps pleinAccent allie la flexibilité d'une agence d'intérim et la qualité d'une agence de sélection. Seuls des emplois pouvant déboucher sur un contrat fixe sont proposés. Pour ce faire, nous pouvons nous appuyer sur 700 collaborateurs passionnés qui aident chaque jour plus de personnes à trouver un emploi. Comptant 230 agences, Accent constitue le plus grand...
-
Operations Support Specialist
il y a 2 semaines
Charleroi, Wallonie, Belgique UNIVERCELLS Temps pleinAt _Univercells_, we are on a mission to make health equally accessible to all. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: biologics for allThanks to a substantial knowledge of the pharmaceutical industry and a strong scientific...
-
Junior IT Support Specialist
il y a 2 semaines
Charleroi, Wallonie, Belgique CellCarta Temps pleinWe are currently recruiting a JuniorIT Support Specialist.Department:ITLocation: Gosselies (Charleroi) - Global role from BelgiumSummaryThe JuniorIT Support Specialist reports to the Team Manager End-User, Cloud and Platform Services Europe-Asia.Main responsibilities Provide firstlineIT support to CellCarta employees with the focus on the Gosselies site...
-
Spécialiste Process
il y a 1 semaine
Charleroi, Wallonie, Belgique Altelios Technology Group Temps pleinEn tant que Spécialiste Process, votre mission est d'assurer la conformité des méthodes et pratiques de fabrication appliquées en Production, par rapport aux exigences des Clients en aéronautiques et des requis internes.Vous avez aussi la responsabilité de supporter l'usine afin d'améliorer sa productivité et sa compétitivité.Votre rôle consistera...
-
Ingé Validation F/H
il y a 2 semaines
Charleroi, Wallonie, Belgique Akkodis Temps pleinPosition description Category OPERATIONS - CONSULTING Job title Ingé Validation F/H Contract Permanent contract Contractual hours Full time Job description Ingénieur Validation AKKODIS Belgique recherche une personne expérimentée dans le domaine pharmaceutique en validation. Quelles sont vos responsabilités? Prévoir...
-
Supply Chain Specialist
il y a 2 semaines
Charleroi, Wallonie, Belgique Akkodis Temps pleinPosition description Category OPERATIONS - ENGINEERING/PRODUCTION Job title Supply Chain Specialist - Life Sciences Sector M/F Contract Permanent contract Job description ABOUT US Akkodis Belgium, the Belgian subsidiary of the Akkodis Technologies Group, is today Number 1 on the of consulting & engineering in Belgium, with more than...
-
Dsp Scientist
il y a 2 semaines
Charleroi, Wallonie, Belgique UNIVERCELLS Temps pleinExothera is a contract research, development, and manufacturing organization (CRDMO) dedicated to virus, viral vector and nucleic acids production. As a __Univercells company_:- , Exothera provides best-in-class bioprocessing expertise that capitalizes on novel manufacturing technologies. The company delivers accelerated discovery services as well as process...
-
Dsp Scientist
il y a 2 semaines
Charleroi, Wallonie, Belgique UNIVERCELLS Temps pleinExothera is a contract research, development, and manufacturing organization (CRDMO) dedicated to virus, viral vector and nucleic acids production. As a __Univercells company_:- , Exothera provides best-in-class bioprocessing expertise that capitalizes on novel manufacturing technologies. The company delivers accelerated discovery services as well as process...
-
Quality Control Specialist
il y a 2 semaines
Charleroi, Wallonie, Belgique Akkodis Temps pleinPosition description Category OPERATIONS - ENGINEERING/PRODUCTION Job title Quality Control Specialist - Life Sciences Contract Permanent contract Contractual hours Full time Job description AKKODIS is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital...
-
Qc Specialist
il y a 2 semaines
Charleroi, Wallonie, Belgique Select Temps pleinLe poste comprend les responsabilités suivantes : Travailler principalement au laboratoire en utilisant des techniques physico-chimiques, notamment l'HPLC. Coordonner les activités liées à l'introduction de nouveaux projets et produits dans le laboratoire. Rédiger des documents techniques tels que des plans d'expériences, des protocoles et des...
-
Automation engineer
il y a 2 semaines
Charleroi, Wallonie, Belgique Akkodis Temps pleinDescription du poste Métier OPERATIONS - CONSULTING Intitulé du poste Automation engineer Contrat CDI Description de la mission Description du poste / Rôle En tant que membre de l'équipe principale de projet de notre client, l'expert en automatisation relèvera du responsable de l'automatisation. À titre d'expert en matière...
-
Brigadier
il y a 2 semaines
Charleroi, Wallonie, Belgique Unique Temps plein**Description**:Nous recherchons un brigadier (h/f/x) pour renforcer l'équipe de votre client. Vous travaillez au sein d'une équipe de 3 opérateurs.Vos tâches en tant que brigadier (h/f/x):- Organiser et coordonner les interventions de l'équipe tout en participant aux activités- Répartir les tâches de chacun dans l'équipe- Organiser le planning de...