QA Specialist Release -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 Specialist Release supports the QA Compliance Manager in several fields: 

  • follow up of customer and/or internal projects by ensuring that all manufacturing steps are performed in compliance with cGMP
  • the Market/Clinical trial Authorization
  • and that controls satisfy to approved specifications

The QA Specialist release will ultimately perform the release of goods and support in SAP implementation.

The QA Specialist Release is involved in the follow up of GMP customer and/or internal projects. 

He/She is the single point of contact between the customer and the Exothera operations teams (mainly QA operations) and/or the internal project team. 

His/her role is to provide a status update to the QA Compliance Manager and to feedback to the customer about ongoing QA topics related to the project (Batch release process, Quality agreement set up, non-conformities status and assessment, change control…).

The QA Specialist Release provides support to the QA Compliance Manager in the release of incoming materials (Starting material, Raw material and/or consumables) and products manufactured by Exothera.

The QA Specialist Release should become the Key User for SAP software and for topics such as the release of incoming materials and products.


Responsibilities:

  • QA Point of contact for GMP customer and/or internal projects
  • Assist to external meetings with the customer
  • Active participant in internal meetings related to customer and/or internal projects
  • Active participant in the GMP readiness follow up with Operations team (GMP documentation in place/in use, equipment released, method validated…)
  • Participate in the redaction of Quality Agreements in collaboration with the customer
  • Ensure that the communication between customer expectations and the operations teams meet customer requirements (under the scope of Quality Agreement)
  • Give feedback and follow up with the customer about various topics (change control, batch record review, non-conformities, method validation, GMP readiness…)
  • Participate to major and critical investigations in collaboration withthe QA operations team
  • Participate actively during customer audit in collaboration with QA tech admin
  • Perform the release of incoming materials (QP role) in collaboration with QA ops, QC and the logistic teams
  • Perform the release of products manufactured by Exothera (QP role) in collaboration with QA ops, QC, the production and logistic team
  • Escalate to Qualified Person any issue which could compromise quality, safety, efficacy of the product
  • Assist the QA compliance manager during Regulatory inspections, Clients audits and internal audits
  • Key user for SAP for release topics during the phase of implementation (procedure creation and review) and after for a day-to-day use
  • 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 Pharmacy with QP accreditation
  • Ability to work in a fast-paced and agile environment
  • Fluent in 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 a team player 
  • Minimum 3 years’ combined experience in a biotechnology/cell and gene therapy environment, covering QA and/or manufacturing
  • Good GMP/GDP knowledge
  • Experience in release of pharmaceutical products