Quality Assurance Manager
Il y a 2 mois
**PRESENTATION OF THE COMPANY**
AUROBAC THERAPEUTICS is a biopharmaceutical company founded in 2022 by three highly renowned life sciences innovation
companies, Boehringer Ingelheim, Evotec and bioMérieux.
Dedicated to addressing high unmet medical needs associated with infections in acute hospital settings, amidst the growing
antimicrobial resistance (AMR) epidemic, AUROBAC is advancing a robust pipeline.
With strong growth ahead, within an international environment, the company is now looking for a Quality Assurance Manager.
**DESCRIPTION**
As Quality Assurance Manager at AUROBAC, you will (1) participate proactively in the implementation and maintenance of the
Quality Management System (QMS) in line with the company's quality policy, and in maintaining a strong quality culture within
the company. (2) You will also contribute to the company's continuous improvement approach, by conducting audits and quality
controls of the company's internal processes, and monitoring the implementation of corrective and preventive actions in
conjunction with all company employees. (3) You will monitor standards and regulations in order to anticipate any changes in
standards applicable to the company's areas of activity and likely to have an impact on its QMS.
The Quality Assurance Manager will report to the Quality and Regulatory Affairs Director and work closely with all teams.
**MISSIONS**
- Development, maintenance and continuous improvement of the company's quality system.
- Drafting and/or checking procedures and other QMS documents.
- Distribution of created/revised QMS documents to relevant employees, and management of associated awareness and training actions.
- Initial QMS training for new employees.
- Coordination and follow-up of periodic reviews of QMS documents.
- Centralizing and processing requests for continuous improvement, non-conformities and complaints.
- Updating and monitoring the implementation of the corrective and preventive action plan (CAPA) in collaboration with the operational teams and third parties.
- Updating of the annual QMS action plan and regular reporting on progress.
- Participation in the preparation of quality management reviews.
- Quality controls and internal process audits to improve the performance of the company's activities.
- Participation in the implementation of the internal audit/quality control plan.
- Planning, execution and follow-up of internal quality audits/controls for the company's key processes.
- Support for the implementation of action plans resulting from external audits (audits of the company's subcontractors).
- Standards and regulations watch
- Monitoring of changes in standards applicable to the company.
- Analyze standards and assess their impact on company’s processes/activities.
- Informing and training teams on changes in standards and regulations.
**TECHNICAL SKILLS**
- Solid knowledge of quality assurance standards (e.g. ISO 9001) and GxP regulations applicable to drug development in an international environment (e.g. GCP, GMP, GLP, GCLP).
- In-depth knowledge of R&D processes (preclinical and clinical stages prior to drug registration) and the players involved.
- Good document management practices.
- Proficiency in audit techniques.
**PERSONNAL SKILS**
- Fluency in English is essential, French would be a major asset.
- Planning, anticipation and organizational skills.
- Observation and listening skills, and excellent communication skills.
- Excellent writing skills.
- Thoroughness and precision.
- Ability to analyze, synthesize and solve problems proactively.
- Ability to be accountable.
- Ability to work both independently and cross-functionally (project mode) in a constantly changing work environment.
**PROFESSIONAL EXPERIENCE**
- Training in pharmacy, engineering or higher science (Bac +5), supplemented by training in quality assurance.
- Junior-level position; 1 to 3 years' experience in managing a quality documentation system in the pharmaceutical R&D sector would be a plus.
**Job Types**: Full-time, Permanent
Status: Cadre
Pay: 40,000.00€ - 80,000.00€ per year
**Education**:
- Master's (required)
**Experience**:
- quality documentation system in the pharmaceutical R&D: 1 year (preferred)
**Language**:
- English (required)
Work Location: In person
-
Quality Assurance Coordinator
il y a 1 mois
Lyon 7e, France AUROBAC THERAPEUTICS Temps plein**PRESENTATION OF THE COMPANY** AUROBAC THERAPEUTICS is a biopharmaceutical company founded in 2022 by three highly renowned life sciences innovation companies, Boehringer Ingelheim, Evotec and bioMérieux. Dedicated to addressing high unmet medical needs associated with infections in acute hospital settings, amidst the growing antimicrobial resistance...
-
Regulatory and Quality Manager
Il y a 6 mois
Lyon 7e, France Dr. Schär France Temps pleinIn our 18 sites in eleven countries, we work for our mission and a global market. All over the world, people with special nutritional requirements trust in the expertise of Dr. Schär. The French medical division includes two Business Units (Renal and Gluten-Free). With a growing company and business, for our site located in Lyon with a permanent contract,...
-
Quality Assurance Project Manager
Il y a 3 mois
Lyon, France Bandai Namco Europe Temps pleinLyon (69) Position Duties As a Quality Assurance Project Manager within the Production Services department, you will be part of the Quality Assurance team. Under the supervision of the Quality Assurance Manager, you will manage the quality control efforts on allocated titles. This includes functionality and compliance testing activities, the follow-up of...
-
Quality Assurance Project Manager
Il y a 3 mois
Lyon, France Bandai Namco Europe Temps pleinBandai Namco Europe is a leading global publisher and developer of entertainment content for platforms including all major video game consoles and PC. BNEU is the western content hub of Bandai Namco Entertainment Inc.(BNEI), and is building its reputation with franchises such as LITTLE NIGHTMARES, THE DARK PICTURES ANTHOLOGY, and the upcoming UNKNOWN 9...
-
Quality Assurance Manager and Data Protection
Il y a 7 mois
Lyon 8e, France AXOLTIS PHARMA Temps pleinAxoltis Pharma is a biotechnology company specialized in the treatment of neurodegenerative and traumatic diseases of the central nervous system. With a strong ambition to accelerate our development, we are now looking for a **Quality Assurance Manager and Data Protection Officer (DPO),** **on a full time or part time position**. He/She will supervise...
-
Regulatory & Quality Manager
Il y a 7 mois
Lyon, France Dr. Schär Temps pleinIn our 18 sites in eleven countries, we work for our mission and a global market. All over the world, people with special nutritional requirements trust in the expertise of Dr. Schär. The French medical division includes two Business Units (Renal and Gluten-Free). With a growing company and business, for our site located in Lyon with a permanent...
-
Office Manager
Il y a 7 mois
Paris 7e, France Quality recrutement Temps pleinLe groupe QUALITY, recrute un Office Manager H/F pour son client présent dans le domaine de l’audit et de la comptabilité. Au sein d’une équipe professionnel et dynamique, vous serez responsable des missions suivantes: - Accueil clients (installation salle de réunion, café, eau ) - Standard téléphonique (max 10/15 appels par jours) - Gestion des...
-
Office Manager
Il y a 6 mois
Paris 7e, France QUALITY RECRUTEMENT Temps pleinLe groupe QUALITY, recrute un Office Manager H/F pour son client présent dans le domaine de l’audit et de la comptabilité. Au sein d’une équipe professionnel et dynamique, vous serez responsable des missions suivantes: - Accueil clients (installation salle de réunion, café, eau ) - Standard téléphonique (max 10/15 appels par jours) - Gestion des...
-
Office Manager
Il y a 6 mois
Paris 7e, France Quality recrutement Temps pleinLe groupe QUALITY, recrute un Office manager H/F pour son client présent dans le domaine de l’audit et de la comptabilité. Au sein d’une équipe professionnel et dynamique, vous serez responsable des missions suivantes: - Accueil clients (installation salle de réunion, café, eau ) - Standard téléphonique (max 10/15 appels par jours) - Gestion des...
-
Quality Assurance Engineer
Il y a 6 mois
Lyon, France Urban Linker Temps pleinLYON - _ - CDI - _ - TECH - _ - 42K À 48K € - JE PARRAINE UN AMI LA SOCIÉTÉ Cette société se développe depuis 10 ans de façon totalement maîtrisée. Ils sont aujourd'hui 150 à travers la France et continuent à grandir. Ils sont les pionniers sur leur secteur d'activité et ils ont su innover, afin de garder cette image de leader sur leur...
-
Quality Manager
Il y a 6 mois
Lyon, France Hyperion Materials & Technologies Temps plein**Summary**: In this key role, The Operations Area Quality Manager is responsible for the overall coordination of the Quality processes with the customer and within the production facilities in their areas of responsibility. Responsible for developing, implementing and administering policies and procedures to achieve the Customer Satisfaction and ensure...
-
Quality Assurance Analyst
Il y a 3 mois
Lyon, France New Tales Temps pleinThis is a fantastic opportunity to join one of most exciting game studios, using leading technology to create new genre-defining games, within our collaborative Action RPG team. New Tales is currently looking for a highly motivated and talented **Quality Assurance Analyst (F/M) in freelance contract **to join our adventure at NEW TALES. **WHAT IS THE JOB...
-
Lab Manager
Il y a 2 mois
Lyon 7e, France AUROBAC THERAPEUTICS Temps plein**Overview** We are seeking a dedicated Laboratory Manager to oversee our laboratory operations and ensure the smooth functioning of all processes. **Duties** - Manage and supervise laboratory staff, including hiring, training, and performance evaluations - Develop and implement laboratory policies and procedures to maintain compliance with regulatory...
-
Project Quality Manager
Il y a 6 mois
Lyon 7e, France FRAMATOME Temps pleinDescriptif du poste Mission Dans le cadre des projets pilotés par la BU Instrumentation et Contrôle (BU I&C), le Responsable Qualité Projet (RQP) a pour principale mission de gérer les aspects Qualité sur l'ensemble des phases d'un projet, depuis la réponse à l'appel d'offre jusqu'à la réalisation opérationnelle du projet puis sa clôture et ceci...
-
Quality Assurance Coordinator
Il y a 6 mois
Lyon, France BI AH France SCS Temps plein**Proposer des traitements innovants en Santé Humaine et Animale - c’est l’engagement de Boehringer Ingelheim depuis plus de 130 ans. Boehringer Ingelheim est une entreprise familiale, engagée dans la recherche et développement, et qui figure parmi les 20 premières entreprises du médicament au monde. **Nos collaborateurs créent tous les jours de la...
-
Quality Control Regional Manager
Il y a 6 mois
Lyon, France HM CLAUSE Temps plein**Type de contrat**: CDI **Temps de travail**: Temps complet **Famille de métier**: PRODUCTION ET OPERATIONS - CONTRÔLE QUALITE **Finalité du poste**: The QC Regional Manager plays a crucial role in the strategic development and execution of operations within the Quality Control (QC) department. As a key member of the QC leadership team, the incumbent...
-
Quality Assurance Lead Manufacturing
Il y a 6 mois
Lyon, France Recordati Group Temps pleinWith its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we...
-
Quality Technician
Il y a 7 mois
Lyon, France RENISHAW Temps pleinA vacancy has arisen for a Quality Engineer (maternity cover) based in Renishaw Mayfield, a French subsidiary of Renishaw Neuro Solutions Ltd, in Chassieu. **Main responsibilities**: - Maintain the quality management system in accordance with the ISO 13485 standard and 21CFR Part 820 Quality System Regulation. - Day to day maintenance of the QMS in...
-
Secrétaire (H/F)
Il y a 6 mois
Lyon, France QUALITY PARE BRISE Temps pleinQuality pare brise Spécialiste du vitrage auto à Comboire. Nous recrutons une secrétaire **DESCRIPTIF DU POSTE**: La liste des tâches est non exhaustive La mission consistera à gérer le planning du technicien, La réception des clients, le standard téléphonique, la prise de RDV, les commandes auprès de notre fournisseur, la préparation des...
-
Secretaire (H/F)
Il y a 6 mois
Lyon, France QUALITY PARE BRISE Temps pleinQuality pare brise Spécialiste du vitrage auto à Comboire. Nous recrutons une secrétaire **DESCRIPTIF DU POSTE**: La liste des tâches est non exhaustive La mission consistera à gérer le planning du technicien, La réception des clients, le standard téléphonique, la prise de RDV, les commandes auprès de notre fournisseur, la préparation des...
