Quality Assurance Specialist

Quality Assurance Specialist

A pharmaceutical laboratory active in the fields of pharmacy and biotechnology is recruiting for the Quality Assurance Department, Quality Assurance Specialist at 80%, for an indefinite period.

TRB Chemedica, an international Swiss pharmaceutical group, active in more than 60 countries, has been a major player for 40 years in the production and distribution of reference therapies for the treatment of ophthalmological, rheumatological, and neurological conditions. A human-sized company, TRB develops a culture where autonomy, trust, and creativity constitute a true foundation for professional fulfillment. The organization of work in project mode allows talents to develop cross-functional skills, thus favoring versatility and internal promotion.

The Vouvry site specializes in the production of rheumatological injectables and a neurological active ingredient. It meets the highest requirements, notably through its GMP certification as well as ISO 13485.

Your mission :

Reporting to the Quality Assurance Manager, you play a key role in the maintenance, monitoring, and improvement of our Quality Management System within our pharmaceutical site.

As a true system quality referent, you ensure the continuous improvement of quality processes, in order to guarantee their compliance with current regulatory requirements, while actively contributing to the performance of the quality system.

In this capacity, you ensure the management of several key processes, including Non-Conformities (NC), Corrective and Preventive Actions (CAPA), Change Controls (CC), Risk management as well as Internal Audits. You ensure their effectiveness, compliance with deadlines, and the relevance of associated performance indicators.

Thanks to your quality expertise and your mastery of electronic document and quality management tools, you participate actively in the modeling and optimization of workflows in the electronic eQMS system Ennov in order to support users and improve process efficiency.

You ensure the monitoring of quality indicators (KPI), the analysis of process performance, the preparation of quality reviews as well as the maintenance of associated documentation. You also participate in quality activities related to the review of batch files in the release process.

Finally, you ensure a back-up role for several strategic quality processes, notably document management, training management as well as supplier management.

Your profile :

Education and experience

• Higher scientific education (Bachelor's, Master's, Engineer, Pharmacist or training deemed equivalent).
• Experience in Quality Assurance preferably in a pharmaceutical, biotechnological or medical device environment.
• Significant experience in the management of quality systems.
• Knowledge of GMP/BPF standards and/or ISO 13485 / ISO 9001 standards.

Technical skills

• Knowledge of systems: Non-Conformities (NC – Deviations) - CAPA - Change Control (CC) - Quality risk management - Internal audits
• Recommended experience in the administration and use of electronic quality management systems (eQMS).
• Demonstrate interest in modeling and optimizing quality workflows in an electronic environment.
• Experience in the implementation and monitoring of quality indicators (KPI).
• Mastery of office tools and aptitude for data analysis.

Personal skills

• Interpersonal skills and ability to collaborate with various interlocutors.
• Autonomy and sense of responsibility.
• Spirit of initiative and ability to propose solutions.
• Proactivity and ability to identify improvement opportunities.
• Excellent analytical and risk management skills.
• Rigor, sense of organization and priority management.
• Ability to manage several activities in parallel and to respect deadlines
• Very good writing skills.

Languages

• Fluent French.
• Good level of professional English, both written and oral.

Start: immediately or to be agreed

Our offer :

Joining TRB Chemedica SA means the assurance of benefiting from:

• The benevolent welcome of a competent and dynamic team, committed to fostering personal development.
• First-rate social benefits (Pension fund, sickness and accident loss of earnings insurance) j4id10449554jm j4it1043jm j4iy26jm