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M2 Quality Control : Medication

Apply for the degree
  • Places available
    25
  • Language(s) of instruction
    English
    French
Présentation
Objectives

At the end of quality control programme, students should be able to:
• Define sampling plans and conformity of sampling
• Define and assess the constitution of the sample library
• Define and organise monitoring of batch stability
• Assess the compliance of analysis techniques
• Perform analyses (quality control of raw material, end product, semi-finished product), validate and interpret the analytical results to assess the conformity of the products
• Assess the conformity of the products based on the manufacturing file and the analytical material
• Identify the maintenance operations of the quality control equipment
• Approve the authenticity of the results in order to be able to generate the certificate of analysis
• Deploy GMP principles in the control activity
• Understand the concepts of quality systems and quality management
• Be familiar with the tools and methodologies used in the pharmaceutical and cosmetics industry to develop improvements in processes and productivity, etc.
• Understand the environment and the specific regulatory constraints concerning health products
This field of competence applies to physical, chemical, and microbiological controls employed on products of natural origin or those resulting from organic synthesis, as well as to biotechnologies

Location
ORSAY
Career prospects

Types of jobs available
- Quality control laboratory manager
- Regulatory affairs officer
- Analytical development director
- Production quality control laboratory manager
- Manufacturing and/or packaging technician
- Technical and regulatory affairs officer
- Management positions in communications companies, regulatory agencies, strategy and development consulting firms
- Assessor in agencies or administrations tasked with health security missions (ANSetc.)
- Head pharmacist

Collaboration(s)
Laboratories

Matériaux et santé.

Programme
Subjects ECTS Lecture directed study practical class Lecture/directed study Lecture/practical class directed study/practical class distance-learning course Project Supervised studies
Projet tutoré: Conduite de projet appliquée à la construction d'un dossier CTD 6 270
Contrôles Physico-chimiques et pharmaco-techniques des médicaments 5 50 20 20
Contrôles microbiologiques des médicaments 5 30 30
Assurance et Management de la qualité dans les industries pharmaceutiques 5 50
Anglais 4 30
Affaires Réglementaires pharmaceutiques 5 50
Subjects ECTS Lecture directed study practical class Lecture/directed study Lecture/practical class directed study/practical class distance-learning course Project Supervised studies
Apprentissage en alternance 30 8760
Modalités de candidatures
Application period
From 15/02/2022 to 23/04/2022
Compulsory supporting documents
  • Curriculum Vitae.

  • All transcripts of the years / semesters validated since the high school diploma at the date of application.

  • Motivation letter.

Additional supporting documents
  • Detailed description and hourly volume of courses taken since the beginning of the university program.

  • The application procedure, which depends on your nationality and your situation is explained here : https://urlz.fr/i3Lo.

  • Certificate of French (compulsory for non-French speakers).

    (Level B2 required)
  • VAP file (obligatory for all persons requesting a valuation of the assets to enter the diploma).

Contact(s)
Course manager(s)
Administrative office
Admission