Beschreibung
Based in Vouvry (Chablais Valaisan)
A pharmaceutical laboratory active in the fields of pharmacy and biotechnology is recruiting for the Validation & Metrology Department a Validation Specialist at 100%, 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.
Validation Specialist
Your contribution to the company:
In this role, you report to the site validation and metrology manager.
You will be responsible for the following activities related to the qualification and validation of equipment, utilities, installations, computerised systems, and manufacturing, cleaning or sterilisation processes:
- Define risk-based qualification/validation strategies and document them,
- Write, coordinate and execute qualification/validation tests,
- Ensure the maintenance of the qualified and validated state of systems,
- Manage documentation related to activities: procedures, instructions, protocols, reports,
- Manage external partners: planning, on-site support and document reviews,
- Participate as an expert in investigations and CAPA, define requirements during acquisition of new equipment, and impact assessments during changes,
- Work closely with engineering, maintenance, production, QA and QC teams,
- Actively participate in audits and inspections.
Your rigour and writing skills enable you to manage all documentation related to your activities.
Thanks to your analytical sense and critical mind, you propose improvements and support their implementation.
Your skills and talents:
You ideally hold a higher university degree or engineering qualification, with experience in the pharmaceutical field and/or medical devices.
You master the principles of qualification/validation and lifecycle within the manufacturing of sterile injectable products.
You have solid knowledge of GMP requirements related to qualification/validation activities and good knowledge of ISO 13485 requirements; mastery of specific pharmaceutical industry standards/references is a plus (ISO 11607 series, ISO 14644, GAMP 5, ICH).
You are fluent in French with good knowledge of English and common IT tools.
Finally, your ability to communicate concisely and effectively, your organisational skills, autonomy, and team spirit are qualities that complete your profile.
Start: immediately or to be agreed
Our offer:
Joining TRB Chemedica SA means the assurance of 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 salary, at least 25 days of holiday per year as well as additional days off beyond 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/