Job type: CDI

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Job content

As Qualification Engineeryou will be working as part of the CordenPharma Fribourg Technical Operations Department. You will manage the qualification plan to maintain the accurate qualification state of new and existing equipments for Manufacturing, Packaging & Engineering. You will define, plan, budget and manage several projects for equipment.

Duties and responsibilities
  • Qualification of equipments : you will execute and monitor the qualification status of the new and existing manufacturing, packaging & engineering equipments and systems, manage the whole process of qualification plan (URS/DQ/FAT/SAT/IQ/OQ/PQ) & create qualification, risk analysis, technical &SOPs documentation
  • Project management: you will create and follow up projects within realistic timelines, on budget as well as in respect of the project Management Best Practices defined by guidelines
  • Improvements: You will lead or participate to investigations, improvements and customers requests implementation for equipment and systems under your responsibilities.
  • Leadership : You will manage external resources (equipment suppliers) and project teams
  • Quality: you will ensure the quality of Qualification activities activities according to GMP guidelines, VMP and internal procedures
Qualifications and skills
  • Engineering degree, Master of Science, in relevant field (Pharmaceutical industry, Chemistry)
  • Min.3 years’ experience with equipment qualification
  • Experience with GMP and FDA regulations
  • Excellent interpersonal skills, analytical thinking and cost consciousness, great communication skills
  • Experience with computer validation (GAMP, 21CFR Part 11, Eudralex Annex 11) & Data Integrity
  • Strong oral & written communication skills (English & French; German a plus)
What we offer
We offer a permanent contract, a competitive salary package and varied and motivating responsibilities.
Interested?
Then we should definitely get to know each other. We look forward to receiving your application via the button Apply.

CordenPharma
est l’une des principales organisations de développement et de fabrication sous contrat (CDMO) d’ingrédients pharmaceutiques actifs (API), d’excipients et de produits pharmaceutiques (DP) et de capacités de conditionnement, avec plus de 2 600 employés dans le monde. Nos services permettent aux entreprises pharmaceutiques et biotechnologiques de fabriquer des médicaments dans le but ultime d’améliorer la vie des gens.

Notre réseau en Europe et aux États-Unis offre des solutions flexibles et spécialisées sur cinq plateformes technologiques : Peptides, lipides et hydrates de carbone ; injectables ; hautement puissants et oncologie ; et petites molécules. Nous visons l’excellence en soutenant ce réseau et nous nous engageons à fournir des produits de la plus haute qualité pour le bien-être des patients.

CordenPharma Fribourg est un fabricant expert de formes de dosage orales solides et de produits pharmaceutiques liquides non stériles, offrant une gamme complète de services allant du développement pharmaceutique pour la phase I-III et la fabrication à l’échelle commerciale, au conditionnement et à la logistique pharmaceutique pour un marché mondial. En tant qu’ancien site d’exploitation de Vifor Pharma, CordenPharma Fribourg apporte plus de 56 ans d’expérience à la plateforme CDMO complète de CordenPharma. Le site est inspecté par Swissmedic, la FDA, l’ANVISA et les autorités russes.

About Us

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Deadline: 05-05-2024

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