Domaine d'activité
Industrie
Catégorie
Fermentation nutrients
Localisation
Maisons-Alfort, France
Type de contrat
Permanent Contract
Experience
5 to 10 years

Description de l'offre

The Quality Engineer reports hierarchically to Quality Director of Biospringer France and functionally to Development and Application Director. The main  missions are :

Specifications Compliance :

  • Manage the process of referencing and approval of products by the Procelys Customers
  • Manage the Signature of Cahier des charges / specification
  • Manage and implement the Signature of Quality agreement
  • Involve in the processus of new cahier des charges with the Procelys’s Customers
  • Integrate and develop the Customers Quality Requirements into Biospringer Quality System  in conjunction with the capability of the process and the recipe
  • Promote solutions to be integrated into the recipe / production process to improve Quality Product for Procelys Customers
  • Integrate all specification into SAP QM
  • Manage and calculate the capability of each SKU following the specifications

Technical support for all Quality Aspects :

  • Ensure a technical support to Customers to promote the use of Procelys Range
  • Propose and participate in the implementation, of the new products and services, and or new implementation solutions
  • Provide quality assistance to Sales peope/ Lab people / Technical Managers to ensure the good understanding  of the Procelys Customers requests and demands
  • Provide the quality assistance to develop the new range and the new products

Claim Investigation in direct relation with Production sites :

Root cause analysis / Corrective action plan :

  • Coordinate the record of customers complaint and the response in relation with Biospringer sites
  • Determine the root cause, propose the corrective action and preventive plan
  • Manage the Customer satisfaction on the Procelys Range

Customers Audits Management :

  • Manage the audits in relation with Biospringer France Sites
  • Organize and determine the corrective/ preventive actions requested by the audits in relation with Biospringer sites
  • Communicate and follow the action plan

Batch Dossier / Batch records :

  • Create and maintain the batch dossier in place
  • Annual quality product review/ validation

Risk analysis :

  • Evaluate the annual risk assessment
  • Manage the annual batch record
  • Manage the risk assessment on each projet
  • Determine the specification to aim a First Time Release at 95%

Change Notification :

  • Manage and communicate the change notification to Procelys customers 

Communication – Quality assistance / communication :

  • Negotiation des quality agreement, specifications, analyses & méthodes, mise en place du principe pre-shipment sample
  • Change managementet notification des changements au client (en s’appuyant sur les dossiers de qualifications)

Continous Improvement / Capability  / Gap analysis  :

  • Manage and calculate the capability of each SKU following the specifications
  • Propose solutions to get the First Time Release to reach 95%
  • Integrate the new Customer’s requirements based on the capability of the process

Tools / KPI & Analysis :

  • KPI : to promote and improve the Procelys product’s portfolio
  • Monthly Reporting   : KPI claims/ Kpi Questionnaires

 

The position is in Maisons Alfort, with punctual business travels, worldwide (< 30%),

Travels in Manufactuering sites : Strasbourg, Cerences.

Qualifications

  • Engineer in Food Industry, Biotech, or pharmaceutical industry or a  Master’s degree in Biochemical Engineering, Biotechnology, Biochemistry,  
  • Minimum of 3 years‘ experience in QA or Production / Process development or Industrialization
  • Minimum experience in Food company and Biotech/ Pharmaceutical company

Skills & Competencies :

  • Key user SAP QM
  • Good english skills, and a synthetic spirit / analysis
  • Good communication skills, in particular the ability to explain technical subjects in a simple way
  • Team player willing to collaborate in a matrix organisation
  • Collaborative teams spirit

Description de l'entreprise

Procelys is an industrial biotechnologies business unit (BU) within the LESAFFRE Nutrition and Health Division. The BU aims to support industrial fermentation industries by providing nutrients and expertise to improve growth and productivity of microorganisms and cell cultures. Our targeted market segments include : biopharma media and diagnostics, food and feed bioingredients, food cultures and probiotics, renewable chemicals, and biocontrol organisms.