Operational QA Engineer (F/M)

We are looking for an Operational QA Engineer (F/M) based in Saint Priest.
Reporting to the Quality Assurance department of BioElpida, now Part of Sartorius , you will be the quality representative for operational aspects of projects from transfer to the GMP stage through to clinical production (sterile biological product, ATMP as well as sterile pharmaceutical raw material).
Grow With Us – Your Responsibilities
In connection with the various projects (biological drug product/drug substance, ATMP, non sterile drug product, raw material for pharmaceutical use) under his/her responsibility:

• Supporting the project manager in steering and leading risk analyses (Environment, Process, Raw materials, definition of AQA, etc.), modifications and Quality approval of these documents.
• Approval of all project documentation (CC, Studies, MBR, BAT......)
• Definition and follow-up of CAPA related to projects managed
• Participation in drafting Product Quality Reviews
• Operational quality monitoring of product batches:
• Production monitoring (quality tour, production debriefing, etc.)
• QA review of batch files
• Certification of batches of raw materials for pharmaceutical use
• QA management of Deviations, RHS/RAT/RHT, REF and REC in relation to its projects / product batches and coordination of associated investigations
• Project quality representative to the customer for assigned projects
• Preparation and follow-up of customer audits and inspections
• Participation in drafting Quality Agreements with customers
• In connection with the QMS : carry out Quality tours according to schedule, quality approval of procedures relating to the operational activities of the Production, Quality Control and Supply Chain departments.
  

What Will Convince Us

• Master degree in pharmaceutical or biotech area or Pharmacist
• Minimum 5 Years of experience in relevant business area
• Good knowledge of GMP for biotechnological products and ideally of ATMP, including investigational medicinal products
• Good Communication skills
• Fluent in English
  

What We Offer
As a growing global life science company, stock listed on the German DAX and TecDAX, Sartorius offers a wide range of benefits:

• Personal and Professional Development: mentoring, leadership programs, LinkedIn Learning, internal seminar offerings
• Work-life Balance: Remote options, flexible work schedules
  

▪ Making an impact right from the start: Comprehensive onboarding, including a virtual online platform – even before joining
▪ Welcoming Culture: Mutual support, team-spirit and international collaboration; communities on numerous topics such as coaching, agile working and business women network
▪ Health & Well-Being: Wide section of health and well-being support such as healthcare plans and health assessment services
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application.
www.sartorius.com/careers