Operational QA Manager
il y a 11 heures
Overview
WE PUSH THE BOUNDARIES OF MEDICINE.
LEAPING FORWARD TO MAKE PEOPLE SMILE
At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We're an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.
Job Purpose
Combined QA/RA/Supply position
- Defines, implements and supervises processes relating to the distribution and operational quality
- Ensures continuous and appropriate supply of drugs
- QA Specialist for the allocated portfolio of products/local pharmaceutical providers
- RA Specialist for the allocated portfolio of products
- Participates in the implementation of the group's Quality Policy/ Quality Guidelines.
Responsibilities
Key Responsibilities:
- Defines and supervises operational quality processes in line with Group directives and local regulations:
- Transportation and overview of the central distribution model for French activities
- Customer complaints, batch recalls, etc.
- Product Quality Reviews
- Shortage management plans
- Ensures continuous and appropriate supply of drugs :
- Monitoring of safety stocks and coordination of supply committee
- Declaration of risks of shortage /shortage to ANSM
- Participates in the continuous improvement of operational quality processes:
- Management of deviations and CAPA
- Definition and monitoring of KPIs
- Participates in quality management reviews
- Risk management
- Raising awareness and training employees
- Evaluates the consequences of regulatory changes and proposes appropriate action plans
- Prepares and submits the annual status report to the ANSM
- Is the reference person for the Veeva modules for which he/she is responsible
- Implements the operational quality processes:
- For the Products for which he/she is responsible (customer complaints, PGP, RQP, stock-outs, recalls....)
- For the local pharmaceutical service providers for which he/she is responsible (QTA, audit, management)
- Implements the operational RA processes:
- Validation of the compliance of promotional/environmental/good use materials and submission to ANSM
- Preparation, validation and distribution of packaging items and product information.
- Participates in health authority inspections
- Is the point of contact for local and global meetings/projects relating to his/her activities
- All activities are implemented within the framework of pharmaceutical regulations, strategy and the company's quality policy.
- Adheres to the promotional information charter and applies it according to the terms of the certification reference framework in force.
- Applies Kyowa Kirin's processes which take into account the regulations in force (promotional information charter, advertising, law governing benefits, transparency, pharmacovigilance, RGPD, etc.).
Qualifications
Position Requirements
- Diploma of Doctor of Pharmacy and Master 2 (Bac +5) in Quality Management;
- Registrable with the CNOP
- Good knowledge of pharmaceutical regulations;
- 5/10 years of experience in Quality Assurance on an "Exploitant" site;
- Operational English required ;
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