Quality & Regulatory Affairs Manager

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

Résumé du poste

Une entreprise pharmaceutique recherche un Pharmacien Responsable Intérimaire à Paris. Le candidat idéal aura au moins 10 ans d'expérience en assurance qualité et réglementation, avec une forte connaissance des normes françaises. Ce poste implique la gestion des audits, la formation des employés et la liaison avec les autorités compétentes.

Qualifications

• Au moins 10 ans d'expérience en QA et RA dans des organisations pharmaceutiques.
• Capacité à travailler dans un environnement international.
• Bonne connaissance de la réglementation française.

Responsabilités

• Responsable de la gestion de la qualité et des audits.
• Formation des employés sur les activités pharmaceutiques.
• Gestion des plaintes qualité et des demandes d'information médicale.

Connaissances

Gestion de la qualité

Audits

Formation

Connaissance de la réglementation française

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

Regulatory Activity

1. DMOS and Transparency Declaration:
   Makes necessary declarations for events and sponsorships related to healthcare professionals or associations
2. Artworks:
   Validates labeling projects, leaflets, and ensures traceability

Support Activity For Tenders

1. Provides all necessary documents for the preparation of tender responses

Key Interface

1. Internal: the entire company
2. External: Competent Authorities, Notified Bodies, unions, subcontractors, suppliers, and consultants

Experience and Capabilities

1. At least 10 years of experience in QA and RA in pharma commercial organizations
2. Ability to work in an international environment
3. Strong knowledge of French regulation in Regulatory
4. Good command in English, both written and spoken
5. Flexibility and teamworking

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