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Senior Quality Assurance Specialist

il y a 1 mois

Paris, Île-de-France AB7 Group Temps plein

We are seeking a highly skilled and experienced Quality Control Manager to join our team at AB7 Group. As the Head of Quality Control, you will be responsible for managing the QC team on site, ensuring the accuracy and reliability of physico-chemical and microbiological tests on raw materials, packaging, and finished products.

Your key responsibilities will include:

  • Management of quality control laboratory staff
  • Analysis planning in coordination with production
  • Conformity control of analysis bulletins
  • Handling of deviations, OOS/OOTs, and CAPAs
  • Document management: revision of methods and procedures
  • Transfer of analytical methods
  • Validation of cleaning of equipment and industrial premises in coordination with the qualification/validation manager
  • Management of analytical equipment, reagents, laboratory waste, climatic chambers, and sample library
  • Training and accreditation of technicians
  • Participation in drug agency and customer audits
  • Participation in risk analyses
  • Regulatory watch/GMP requirements inherent to the quality control laboratory
  • Support QC subsidiary AB7 America

Requirements:

  • 5 years' higher education in chemistry or as a pharmacist
  • At least 5 years' experience as a QC manager in the pharmaceutical sector, plus proven experience in team management
  • Good skills in analytical techniques, particularly chromatography
  • Strong communication and interpersonal skills, with the ability to work effectively with cross-functional teams
  • Fluency in English