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Isalys Life Sciences

Quality Assurance Consultant

Quality Assurance Consultant

France

our method of excellence

Ambition and development

Our development plan for 2025 – 2030 aims to exceed €115 million in revenue by the end of 2030, with an ISA team of over 750 engaged and committed members working to elevate each subsidiary to the highest level.

As a Quality Assurance Consultant in the Pharmaceutical Industry, you are responsible for ensuring that pharmaceutical products comply with quality standards, Good Manufacturing Practices (GMP) and current regulations.

You will play a key role in implementing and monitoring quality management systems to ensure compliance and continuous improvement of industrial processes.

Your missions will be as follows: 

·        Compliance assessment: conduct internal and external audits to assess the compliance of processes, products and quality systems with regulatory requirements and internal company standards.

·        Identify non-conformances and propose corrective and preventive actions (CAPA) in order to improve quality performance.

·        Implementation of GMP and quality standards: assist the company in the implementation of Good Manufacturing Practices (GMP) and local and international regulatory requirements (e.g. FDA, EMA).

·        Assist in drafting, updating and implementing quality procedures and documents (SOPs, work instructions, protocols, reports, etc.).

·        Monitoring of quality indicators: analyse quality performance data, prepare reports and recommend improvements based on the results obtained.

·        Participate in the management of customer complaints and the root cause analysis of quality incidents.

·        Train internal teams on quality and GMP requirements, ensuring understanding of processes and ongoing compliance.

·        Support in the validation and qualification of equipment: support the teams in the qualification of equipment, manufacturing processes, and computerised systems (CSV validation).

Profile required

Holding a Master's degree (Bac +5) in Pharmacy, Biotechnology, Engineering or a similar field.

You have a minimum of 3 to 5 years of experience in the field of quality assurance within the pharmaceutical industry.

Technical skills:

·        Proficiency in GMP, FDA, EMA standards, and other pharmaceutical regulations.

·        Knowledge of quality management tools, audit techniques, and validation methods.

·        Experience in quality documentation and CAPA (Corrective and Preventive Actions) management.

Interested?

Fill in your contact information and your CV

Email: career-ls@isalys.eu