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Validation Specialist

TRB CHEMEDICA SA

Employment type
Full-time
Location
Vouvry
First posted
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Based in Vouvry (Chablais Valaisan) Validation Specialist Based in Vouvry (Chablais Valaisan) A pharmaceutical laboratory active in the fields of pharmacy and biotechnology is recruiting for the Validation & Metrology Department Validation Specialist at 100%, for an indefinite period. 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 constitute a true foundation for professional development. The organization of work in project mode allows talents to develop transversal skills, thus promoting 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 certification to GMP and ISO 13485. Validation Specialist Your contribution to the company: In this function, you will report to the validation and metrology manager of the site. You will be in charge of the following activities related to the qualification and validation of equipment, utilities, installations, computerized systems, and manufacturing, cleaning or sterilization 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, Management of documentation related to activities: procedures, instructions, protocols, reports Management of external partners: planning, on-site support and review of documents, Participation as an expert in investigations and CAPA, in the definition of needs when acquiring new equipment, and in impact assessments during changes, Close collaboration with the engineering, maintenance, production, AQ and CQ teams, Active participation in audits and inspections. Your rigor and writing skills allow you to manage all the documentation related to your activities. Thanks to your analytical mind and critical spirit, you propose improvements and accompany their implementation. Your skills and talents: You ideally have a higher education degree or engineering degree, with experience in the pharmaceutical field and/or medical devices. You master the principles of qualification/validation, and the life cycle in the context of sterile injectable product manufacturing. You have a solid knowledge of GMP requirements related to qualification/validation activities and good knowledge of ISO 13485 requirements, mastery of industry-specific standards/references is a plus (ISO 11607, ISO 14644, GAMP 5, ICH). You master the French language with good knowledge of English and usual computer tools. Finally, your ability to communicate concisely and effectively, your sense of organization, autonomy, and team spirit are all qualities that perfect your profile. Entry: immediately or by agreement Our offer: Joining TRB Chemedica SA is the assurance of benefiting from: The welcoming of a competent and dynamic team, having at heart the development of personal development. First-class social benefits (pension fund, loss of earnings insurance in case of illness and accident). A 13th salary, minimum 25 days of vacation per year as well as additional days off in addition to the official holidays of the canton of Valais Free parking, preferential rates for meals Advantages offered by regional partners We invite you to send us your complete application file (CV, cover letter, work certificates and diplomas). Find our job openings on our website: jpid208d374jm jpit0625jm jpiy26jm

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