Quality Regulatory Manager

REDDY PHARMA SAS; Paris; Sur place; EUR 55 000 - 85 000; Plein temps

Résumé du poste

Join a forward-thinking pharmaceutical establishment as a Responsible Pharmacist and General Manager. In this pivotal role, you will oversee audit management, quality system maintenance, and training coordination, ensuring compliance with stringent regulations. Your expertise will guide the team in managing quality complaints, medical information requests, and regulatory activities, making a significant impact on the organization’s success. With a strong focus on collaboration and communication, this position offers the chance to thrive in an international environment while contributing to the quality and safety of pharmaceutical products.

Qualifications

• 10+ years of experience in QA and RA within pharmaceutical organizations.
• Strong knowledge of French regulations and ability to work internationally.

Responsabilités

• Manage audits, training, and quality systems to ensure compliance.
• Handle deviations, CAPAs, and change control processes effectively.

Connaissances

Quality Assurance (QA)

Regulatory Affairs (RA)

Audit Management

Training Coordination

Change Control Management

Medical Information Management

Quality Complaints Handling

SOP Maintenance

Formation

Master's in Pharmacy or related field

Description du poste

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 :

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. Change Control :
   • Manages Change Control, initiation, approval, closure
7. 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
8. Medical Information Requests :
   • Receives, records, and responds to medical information requests
   • Performs monthly reconciliation
9. Quality Complaints :
   • Receives, records, and processes quality complaints in connection with the Qualified Person and manufacturing sites
   • 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
   • Support Activity For Tenders :
     • Provides all necessary documents for the preparation of tender responses
   • Key Interface :
     • Internal : the entire company
     • External : Competent Authorities, Notified Bodies, unions, subcontractors, suppliers, and consultants
   • 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