Quality Manager Pharma - Lyon e, France - FED Ingénierie

FED Ingénierie
FED Ingénierie
Entreprise vérifiée
Lyon e, France

il y a 3 semaines

Sophie Dupont

Posté par:

Sophie Dupont

beBee Recruiter
Description

Le cabinet de recrutement FED Ingénierie, spécialisé sur l'ensemble des métiers techniques et industriels, recherche pour son client spécialisé dans la pharmaceutique : Un Quality Manager Pharma (H/F) en CDI situé à Lyon Poste à pourvoir immédiatement k selon profil

Votre fonction:


QA/QC duties:

  • Responsible to release products based on a documentation verification, in compliance with applicable regulations and relevant quality standards;
  • Ensures continuous qualification of existing products and supports development of new portfolios; ensures data management and its validity (respect of data integrity rules)
  • Validates manufacturer's certificates of analysis (CoA) and creates CoA's for customers; as well as other certificates (CoO etc.)
  • Collaborates with external laboratories for sample analysis if applicable/ if needed
  • Handles complaints related to product quality; oversees distribution service complaints and provides support if needed
  • Enforces regulatory compliance within the organization with Pharmaceutical Intermediate & Specialty Chemicals (PI SC) focus
  • Responds to internal colleagues for any type of technical productrelated questions (per BU)
  • Participates in organization and preparation of customer Quality Audits
  • Participates in organization and preparation of Internal Audits of

QMS:

  • Engages with European Quality Team (ability to work in a matrix organization)
  • Works on continuous improvement of the existing processes
  • Contributes to processes and procedures creations
  • Monitors validity of existing Actylis and Suppliers certificates (GMP/ GDP/ ISO/ etc.) (maintenance of Supplier Qualifications)
  • Executes work in line with the established internal rules and Standard Operating Procedures (SOP) and applicable norms
  • Monitors changes in product related regulations (BU)
  • Executes assigned training (QMS)

Votre profil:


  • Scientific background in Biology, Chemistry, Biochemistry or Biotechnology
  • At least 5 years relevant experience in working with Quality Management Systems, Quality Assurance / Quality Control
  • Product Stewardship experience (regulatory support, REACH regulation knowledge etc.)
  • Knowledge of API GMP guidelines and practices, ISO 9001:2015 are required.
  • Fluent English required, German is a significant plus.
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