Regulatory and Quality Compliance 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 superviser les activités de qualité et de réglementation. Avec au moins 10 ans d'expérience, vous serez responsable des audits, de la formation, et des relations avec les autorités compétentes. Ce rôle exige une connaissance approfondie des réglementations françaises et une bonne maîtrise de l'anglais.

Qualifications

• Au moins 10 ans d'expérience en QA et RA dans des organisations pharmaceutiques.
• Capacité à travailler dans un environnement international.
• Bonne maîtrise de l'anglais, à l'écrit et à l'oral.

Responsabilités

• Organiser et participer aux audits des sous-traitants.
• Maintenir le système de qualité et réviser les procédures locales.
• Gérer les demandes d'informations médicales et les plaintes de qualité.

Connaissances

Gestion de la qualité

Audits

Formation

Connaissance des réglementations françaises

Compétences en anglais

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 : Maintains the quality system, revises local procedures, reviews projects proposed by the EU-QA headquarters, ensures dissemination of new SOPs, organizes training, and monitors monthly quality indicators of the subsidiary.
4. PQR : Reviews PQRs related to the Europe site and 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, drug destruction, and 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 affairs.
4. Good command of English, both written and spoken.
5. Flexibility and teamworking skills.