Regulatory Affairs and Quality ManagerRegulatory Affairs and Quality Manager

REDDY PHARMA SAS; Paris; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

Reddy Pharma SAS recherche un Pharmacien Responsable Intérimaire pour gérer les activités de qualité et de réglementation à Paris. Le candidat idéal aura au moins 10 ans d'expérience en assurance qualité dans le secteur pharmaceutique, avec une bonne maîtrise des réglementations françaises et de l'anglais. Ce poste implique des responsabilités variées, allant de la gestion des audits à la formation des employés.

Qualifications

• Au moins 10 ans d'expérience en QA et RA dans des organisations pharmaceutiques.
• Capacité à travailler dans un environnement international.

Responsabilités

• Gérer les audits et les formations liées aux activités pharmaceutiques.
• Maintenir le système de qualité et réviser les procédures locales.
• Traiter les plaintes de qualité et gérer les demandes d'informations médicales.

Connaissances

Connaissance des réglementations françaises

Anglais écrit et parlé

Flexibilité

Travail en équipe

Description du poste

AS INTERIM RESPONSIBLE PHARMACIST

Reddy Pharma SAS, a pharmaceutical establishment operating in accordance with Article R 5124-2,3° of the Public Health Code, has appointed a Responsible Pharmacist, General Manager, in accordance with the terms of Article L. 5124-2 of the Public Health Code. The Interim Responsible Pharmacist is granted, for the replacement periods, the same powers and attributions as those conferred on the Responsible Pharmacist; he effectively exercises them during the replacement period (R-5112-7 of the Public Health Code).

MAIN TASKS OF THE POSITION :

You will be responsible for the following areas :

QA Manager :

1. Audit Management :
   • Organizes and participates in subcontractor audits
   • Follows up until closure
   • Establishes and revises contracts (QTA)
2. Training :
   • Records training related to pharmaceutical activities for each employee
   • Prepares and conducts annual GDP training
3. Quality System Management :
   • SOPs : maintains the quality system
   • Revises local procedures
   • Reviews projects proposed by the EU-QA headquarters
   • Ensures the dissemination of new SOPs
   • Organizes training for the team
   • Quality indicators : monitors the monthly quality indicators of the subsidiary and transmits them to the QA-EU department
4. PQR :
   • Reviews PQRs related to the Europe site
   • Completes documents related to the operating activity
5. Deviations and CAPAs :
   • Writes deviations and CAPAs and follows their progress until closure
6. Relations with the Depository Site :
   • Liaises with the depository for batch tracking, product distribution, returns management, and drug destruction
   • Is responsible for the "commercial release" of drug batches
7. Medical Information Requests :
   • Receives, records, and responds to medical information requests
   • Performs monthly reconciliation
8. Quality Complaints :
   • Receives, records, and processes quality complaints in connection with the Qualified Person and manufacturing sites
9. Regulatory Activity :
   • DMOS and Transparency Declaration : makes necessary declarations for events and sponsorships related to healthcare professionals or associations
   • Artworks : validates labeling projects, leaflets, and ensures traceability
10. Support Activity For Tenders :
    • Provides all necessary documents for the preparation of tender responses
11. Key Interface :
    • Internal : the entire company
    • External : Competent Authorities, Notified Bodies, unions, subcontractors, suppliers, and consultants
12. Experience and capabilities :
    • At least 10 years of experience in QA and RA in pharma commercial organizations
    • Ability to work in an international environment
    • Strong knowledge of the French regulation in Regulatory
    • Good command in English, both written and spoken
    • Flexibility and teamworking

Location :

Quality Regulatory • Paris, Paris (75); Ile-de-France, France