Responsible Pharmacist F/H

Job description

Location : Rueil-Malmaison (92), HQ Unilever France

Starting Date : As soon as possible

Activities and responsabilities:

QUALITY ASSURANCE
· Assist the Qualified Person/RP
· Develop, implement and manage the company Quality Management System (QMS)
· Plan, manage and support both internal and external audits as well as client audits and regulatory inspections to ensure compliance with the GMP Audit Program and regulatory requirements
· Handle complaints for products marketed by the company
· Manage the CAPA system and ensure that appropriate corrective, preventive actions are implemented
· Write, edit, review, update and implement policies and Standard Operation Procedures (SOPs)
· Develop and review technical and safety agreements with partners
· Manage documentation system related to contracts with suppliers and partners
· Analyze of product quality reviews with suppliers
· Manage quality reviews for “exploitant” activities
· Develop an internal training program, plan and perform training to internal key customers
· Manage archiving system for pharmaceutical documentation
· Manage pharmaceutical activities with the selected warehouse
· Ensures traceability of batches and potential recalls
· Implement risk analysis to prevent out of stock situations
· Support activities in order to ensure compliance of sales force providers
· Prepares annual site master file and annual reports for ANSM
· Free samples management
· Manage activity related to parallel imports and counterfeit / falsified products
· Write and prepare dossiers for modifications concerning the pharmaceutical site to ANSM
· Ensure reconciliation of calls between customer support and pharma call center

1.1 REGULATORY AFFAIRS

· Ensure review and quality control of packaging materials
· Obtain and manage all Change Controls

1.2 PHARMACOVIGILANCE

· Ensure reconciliation between pharmaceutical complaints and pharmacovigilance data
· Follow-up the activity of the pharmacovigilance provider

1.3 GENERAL
At least one Interim RP must be appointed ; the Interim RP has the same responsibilities as the RP when acting on her/his behalf, e.g.:
· Legally responsible towards French Health Authorities of pharmaceutical operations done within the company;
· Responsible for the respect of regulations concerning medical information and advertising of the products marketed in France;
· Responsible of the follow-up and withdrawal of batches;
· Legally responsible for drug safety monitoring (even if delegated);
· Guarantees that the requirements of pharmaceutical industry regulations are strictly respected;
· Guarantees the quality of the products marketed by the company;
· Represents the company with health authorities (ANSM, HAS,…) and pharmaceutical trade associations
· Handles out of stock situations
One Deputy Pharmacist must be appointed 20 2. REQUIRED TRAINING

· Pharmacovilange
· Training on products
· GMP and GDP

3. MAIN CONTACTS AND RELATIONS

3.1 INTERNAL

· With marketing and sales
· With pharmacovigilance
· With supply

3.2 EXTERNAL

· With health authorities
· With suppliers, subcontractors, partners, …
· With Corporate
Profile/Required Skills:

10 - 15 years' experience in a regulated pharmaceutical environment with at least 4 years' experience in a line management or decision-making quality role.
Experience with Quality Management System and internal/external/client audits and inspection.
Experience in training management.
Excellent organization and coordination skills. Good intrapersonal skills. Autonomy.
Good stress management, ability to set priorities.

Diploma: Pharmacist – can register the diploma with Section B or National Council of Pharmacists (mandatory)

IT : Word, Excel, Power Point
English : Fluent