Offres d'emploi

Le poste

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.

To apply, please send your CV and cover letter application to jobs@aurobac-tx.com mentioning the reference ATX24-08.

For more information on how we process your personal data, please visit https://aurobac-tx.com/privacy-statement/

 

Voir l'annonce sur le site de l'entreprise

 

 

L'entreprise

AUROBAC THERAPEUTICS

 

AUROBAC THERAPEUTICS is a biopharmaceutical company created in 2022 by 3 renowned life sciences innovation companies, Boehringer Ingelheim, Evotec and bioMérieux, to become a global leader in the fight against bacterial infections, Antimicrobial Resistance (AMR) and their consequences in acute hospital settings.
We focus our efforts to develop the next generation of antimicrobial and acute care products, following a targeted precision medicine approach, i.e. associated with rapid diagnostics to support product use.