Quality Assurance Systems Specialist – Exothera

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 Specialist 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
  • Demonstrate day-to-day application of the company’s values
  • Excellent influential skills
  • Strong in communication and team player