Quality Assurance Specialist

About the job

Quality Assurance Specialist

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

TRB Chemedica, a Swiss international 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 form a true foundation for professional fulfilment. The project-based work organisation allows talents to develop cross-functional skills, thus promoting versatility and internal promotion.

The Vouvry site specialises 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 maintaining, monitoring and improving our Quality Management System within our pharmaceutical site.

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

As such, you manage several key processes, including Non-Conformities (NC), Corrective and Preventive Actions (CAPA), Change Controls (CC), Risk Management and Internal Audits. You ensure their effectiveness, respect of deadlines and relevance of associated performance indicators.

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

You monitor quality indicators (KPIs), analyse process performance, prepare quality reviews and maintain associated documentation. You also participate in quality activities related to batch record review in the release process.

Finally, you act as a back-up for several strategic quality processes, including document management, training management and supplier management.

Your profile:

Education and experience

• Scientific higher education (Bachelor, Master, Engineer, Pharmacist or equivalent training).
• Experience in Quality Assurance preferably in a pharmaceutical, biotechnological or medical device environment.
• Significant experience in quality system management.
• Knowledge of GMP/GDP guidelines 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 administration and use of electronic quality management systems (eQMS).
• Demonstrated interest in modelling and optimising quality workflows in an electronic environment.
• Experience in setting up and monitoring quality indicators (KPIs).
• Proficiency in office tools and data analysis skills.

Personal skills

• Good interpersonal skills and ability to collaborate with various stakeholders.
• Autonomy and sense of responsibility.
• Initiative and proactivity.
• Proactivity and ability to identify improvement opportunities.
• Excellent analytical and risk management skills.
• Rigor, organisational skills and priority management.
• Ability to manage several activities simultaneously and meet deadlines.
• Very good writing skills.

Languages

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

Start: immediately or to be agreed

Our offer:

Joining TRB Chemedica SA means benefiting from:

• The warm welcome of a competent and dynamic team, committed to fostering personal development.
• First-class social benefits (pension fund, loss of earnings insurance for illness and accident).
• A 13th month salary, at least 25 days of holiday per year as well as additional days off on top of the official public holidays of the canton of Valais.
• Free parking, preferential meal rates.
• Benefits offered by regional partners.
• We invite you to send us your complete application file (CV, cover letter, work certificates and diplomas).

Find our vacancies on our website: https://www.trbchemedica.com/careers/