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:
Audit Management:
o Organizes and participates in subcontractor audits
o Follows up until closure
o Establishes and revises contracts (QTA)
Training:
o Records training related to pharmaceutical activities for each employee
o Prepares and conducts annual GDP training
Quality System Management:
o SOPs: maintains the quality system
o Revises local procedures
o Reviews projects proposed by the EU-QA headquarters
o Ensures the dissemination of new SOPs
o Organizes training for the team
o Quality indicators: monitors the monthly quality indicators of the subsidiary and transmits them to the QA-EU department
PQR:
o Reviews PQRs related to the Europe site
o Completes documents related to the operating activity
Deviations and CAPAs:
o Writes deviations and CAPAs and follows their progress until closure
Change Control:
o Manages Change Control, initiation, approval, closure
Relations with the Depository Site:
o Liaises with the depository for batch tracking, product distribution, returns management, and drug destruction
o Is responsible for the "commercial release" of drug batches
Medical Information Requests:
o Receives, records, and responds to medical information requests
o Performs monthly reconciliation
Quality Complaints:
o Receives, records, and processes quality complaints in connection with the Qualified Person and manufacturing sites
Regulatory Activity:
DMOS and Transparency Declaration:
o Makes necessary declarations for events and sponsorships related to healthcare professionals or associations
Prepares mandatory declarations (Inventory, sales declarations, Shortage Management Plans, etc.)
Artworks:
o 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
Flexibility and teamworking