Isalys Life Sciences
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.