Quality Management System Specialist

Il y a 2 mois


Lyon, France KELLY OCG Temps plein

**KELLY OCG,** est une société de prestation de services intellectuels dédiée aux industries de santé.
Notre savoir-faire, le domaine spécifique des Life Sciences.
Nous accompagnons nos clients dans la réalisation de leurs projets grâce à nos collaborateurs experts dans différents métiers scientifiques, tout au long du développement d’un médicament et/ou produits de santé et de son évaluation.
Ensemble nous contribuons à la réussite des prestations dans le cadre d'un travail collaboratif, et adaptons les prestations aux besoins spécifiques de nos clients.
Nous recrutons **un(e) Quality Management System specialist H/F** pour le compte de notre client.

Dans le cadre de vos fonctions vos principales responsabilités seront les suivantes:
Based on Business needs, the objectives of this mission are the Implementation and maintenance of company quality policy and identified regulation/guidelines for activities conducted within Research and Translational Medicine perimeter.
An experience in GLP is appreciated.
**Main tasks**:

- To remain informed of any implementation or changes in international and/or national regulations/guidelines related to his/her activities within R&D GxP and to propose any appropriate action (e.g. change in QDs, process).
- To provide adequate support and advice to the concerned staff by ensuring the implementation of the quality policy and quality documents.
- To lead as QD Owner or to participate as QA Representative in the creation, update of QDs supporting the Process and QD Owners.
- To be responsible for ensuring that regulatory and ICH requirements are implemented in QDs, wherever appropriate, and for coordinating the writing, updating and validation according to central policy and QDs.
- To provide advice and support to R&D staff in the implementation of their training process.
- To create/update Quality training material (GCP, quality guidelines and regulation) and to participate in the training of R&D staff.
- To contribute to the Quality Risk Prevention (definition, follow-up and maintenance) for projects for which (s)he is responsible, with the other R&D QA Divisions and concerned structures.
- To follow the implementation of the Corrective Actions & Preventive Actions (CAPA), if any, for projects for which (s)he is responsible.
- To participate in regulatory inspections in supporting roles. To assist with the preparation, execution, preparation of responses to health authorities and follow-up

**Profils**
- At least 5 years’ experience in the pharmaceutical industry with knowledge in quality management, compliance (GxP, data privacy).
- Experience in laboratory environment and GLP would be appreciated.
- Solutions oriented.
- Excellent written and oral communication.
- Ability to work in a transversal manner, sense of contact.
- Proactive to predict issues and solve problems.
- Rigour
- English
- Good knowledge and practice of Pack Office (PowerPoint, Excel,)

Type d'emploi : Temps plein, CDI, Indépendant / freelance
Statut : Cadre

Salaire : 45 000,00€ à 55 000,00€ par an

Avantages:

- Participation au transport
- RTT
- Titre-restaurant

Programmation:

- Du lundi au vendredi

Formation:

- Bac +5 (Master / MBA) (Optionnel)

Lieu du poste : Un seul lieu de travail

Date de début prévue : 17/04/2023


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