Quality Assurance Systems Specialist- Exothera

il y a 5 jours

Charleroi, Belgique UNIVERCELLS Temps plein

**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 processdevelopment/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.

**MISSION**:
The
** QA Systems Special**
**ist** is the Point of contact for eQMS inside the QA team, the point of contact for QMS for the Exothera team and the owner of systems: risk assessment, customer audits and inspections.

**RESPONSIBILITIES**:

- Single point of contact for all topics regarding QMS (Deviation, change control, CAPA, audits, risk assessment, training, documentation )
- Interaction with QA Univercells for change/improvement in QMS system
- Risk assessment owner: collect the quality risks, document with the owner, follow up of risk with associated mitigation
- Quality council owner: preparation, presentation to leadership team, follow up of actions
- Change control owner: lead the change control committee board, follow up of Change control (including administrative closure)
- Audits/inspections leader: lead the preparation, coordination, manage the audit response and CAPA follow up.
- SPOC for eQMS inside the Exothera QA team
- Support questions from operations teams related to eQMS system (Mastercontrol)
- SPOC and point of contact for audit related to quality system topics: deviations, change control
- Be part of the implementation of eQMS modules (testing with QA Univercells, Exothera procedure drafting, testing and training for Exothera team)
- Respect EHS rules and instructions
- Collaborate with employer, EHS department and hierarchical line in:

- performing risk analysis
- accident/incident investigations
- proposal of preventive/corrective measures regarding to avoid risks.
- Attend the EHS training sessions organized
- Flag up risks and unsafe situations

**REQUIREMENTS and QUALIFICATIONS**
- M. Sc. or equivalent in scientific discipline
- Minimum 3 years’ combined experience in biotechnology/cell and gene therapy environment, covering QA and/or manufacturing
- Good GMP/GDP knowledge
- Ability to work in fast-paced and agile environments
- Fluent English (both written and spoken), French is an asset
- Excellent influential skills
- Strong in communication and team player

  • QA System Specialist

    Il y a 7 mois

    Charleroi, 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...

  • QA Operations Specialist

    Il y a 7 mois

    Charleroi, Belgique UNIVERCELLS Temps plein

    **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...

  • QA Specialist Release

    Il y a 7 mois

    Charleroi, Belgique UNIVERCELLS Temps plein

    At **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 all! **Exothera**, a Univercells affiliate, is a Contract Research, Development, and...

  • Qc Outsourcing Scientist

    Il y a 7 mois

    Charleroi, Belgique UNIVERCELLS Temps plein

    **Exothera **is a contract research, development, and manufacturing organization (CRDMO) dedicated to viral vectors 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 group. The...

  • (Junior) Dsp Scientist

    Il y a 7 mois

    Charleroi, Belgique UNIVERCELLS Temps plein

    Exothera 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...

  • Technical Buyer

    Il y a 7 mois

    Charleroi, Belgique UNIVERCELLS Temps plein

    Exothera is a contract development and manufacturing organization (CDMO) dedicated to virus / viral vector production and nucleic acids. 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...

  • Dsp Techncian R&d

    Il y a 6 mois

    Charleroi, Belgique UNIVERCELLS Temps plein

    **Exothera **is a contract research, development, and manufacturing organization (CRDMO) based in Jumet, dedicated to viral vectors 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...

  • Qc Laboratory Support

    Il y a 7 mois

    Charleroi, Belgique UNIVERCELLS Temps plein

    **Exothera **is a contract development and manufacturing organization (CDMO) dedicated to virus / viral vector production and nucleic acids. 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...

  • Analytical Scientist

    il y a 5 jours

    Charleroi, Belgique UNIVERCELLS Temps plein

    **MISSION** Operating within the perimeter of the Analytical Science laboratory of Exothera, the **BioAssay** **Scientist (Immuno Assays field) **is responsible for developing, transferring, and qualifying analytical methods in support of the bioprocess development activities of Exothera. She/He will work closely with Analytical Technicians to plan and...

  • Analytical Laboratory Manager na

    Il y a 8 mois

    Charleroi, Belgique UNIVERCELLS Temps plein

    At 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 all! **Exothera**, a Univercells affiliate,is a Contract Research, Development, and Manufacturing...

  • Production Support Technician

    Il y a 7 mois

    Charleroi, Belgique UNIVERCELLS Temps plein

    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...

  • Qc Technician

    il y a 1 jour

    Charleroi, Belgique UNIVERCELLS Temps plein

    At **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 all! **Exothera**, a **Univercells affiliate**, is a contract development and manufacturing...

  • Qc Laboratory Lead

    Il y a 7 mois

    Charleroi, Belgique UNIVERCELLS Temps plein

    **Exothera** is a contract research, development, and manufacturing organization (CRDMO) dedicated to viral vectors 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 group. The...

  • Production Technician Dsp

    Il y a 7 mois

    Charleroi, Belgique UNIVERCELLS Temps plein

    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...

  • Cmc & Regulatory Associate - Exothera

    Il y a 7 mois

    Charleroi, Belgique UNIVERCELLS Temps plein

    **MISSION** As **_CMC and Regulatory Associate _**you will be responsible for delivering the CMC strategy within internal and external projects through their lifecycle under the supervision and guidance of the Lead and/or Manager, and for delivering on CMC-related specific client requests to projects (e.g., contribution to the writing or reviewing of CMC...

  • Quality Assurance Representative Aviation

    Il y a 7 mois

    Charleroi, Belgique Werkenvoor.be Travailler.pour Temps plein

    **Code de sélection**: - AFG24056**Langue**: - Français**Diplôme**: - Bachelier**Type de contrat**: - Statutaire**Niveau de fonction**: - B**Type de recrutement**: - Recrutement externe**Durée**: - Durée indéterminée**Lieu de travail**: - 6000 Charleroi**Temps plein/temps partiel**: - À temps plein**Résumé**: **Contenu de la...

  • Business Development Director Us

    il y a 1 semaine

    Charleroi, Belgique UNIVERCELLS Temps plein

    **_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...

  • Safety Assurance Manager

    Il y a 7 mois

    Charleroi, Belgique ALSTOM Temps plein

    Req ID:426477 We create smart innovations to meet the mobility challenges of today and tomorrow. We design and manufacture a complete range of transportation systems, from high-speed trains to electric buses and driverless trains, as well as infrastructure, signalling and digital mobility solutions. Joining us means joining a truly global community of more...

  • Safety Assurance Manager

    il y a 1 semaine

    Charleroi, Belgique Alstom Temps plein

    **Req ID**: 305043 Leading societies to a low carbon future, Alstom develops and markets mobility solutions that provide the sustainable foundations for the future of transportation. Our product portfolio ranges from high-speed trains, metros, monorail, and trams to integrated systems, customised services, infrastructure, signalling and digital mobility...

  • Analytical Development Technician

    Il y a 7 mois

    Charleroi, Belgique UNIVERCELLS Temps plein

    At **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 all! **Exothera**, a **Univercells affiliate,**is a Contract Research, Development, and...