QA System Specialist
il y a 3 jours
**_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 group_**:
- . The company delivers accelerated discovery services as well as process development/optimization to rapidly reach GMP clinical and commercial production of viral vectors and nucleic acids. At _
**_Exothera_**:
- and _
**_Univercells_**:
- , Our mission is to make life-changing therapies available 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.
- Specialist for eQMS inside the Exothera QA team
- Support questions from operations teams related to eQMS system (Mastercontrol -> ETQ)
- SPOC and point of contact for audit related to quality system topics: deviations, change control
- Potentially 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
Attention all applicants,
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