Process Expertise & Validation Specialist (h/f) in Bulle

veröffentlicht
Kontakt
Kian Razavi, Randstad UCB Bulle
Jobtyp
Temporär
jetzt bewerben

job details

veröffentlicht
Ort
Bulle, Fribourg
Sektor
Bau
Jobtyp
Temporär
Referenznummer
209836-73
Kontakt
Kian Razavi, Randstad UCB Bulle
Telefon
079 515 13 46

Stellenbeschreibung

Are you analytical with innovative touch? UCB is constantly seeking the improvement for the sake of patients! Randstad is proud of searching this profile until end of the year 2022.

The mission:

  • Support process troubleshooting and continuous improvement for the pharma processes by performing small-scale studies in our lab,Schedule,
  • prepare and execute small-scale studies and experimental activities, and write associated protocols and reports,
  • Ensure adherence to the site Validation Master Plan,
  • Lead process validation and cleaning validation/verification, including the definition of the validation strategy:
    • Drive and write validation risk assessments, change-over protocols and change controls for current and new processes as Validation & Process Expert,
    • Write validation plans, protocols and reports,Provide expertise in validation and process knowledge during investigations,
  • Change Controls and projects for chemical and pharmaceutical processes,
  • Implement new processes and support the Tech Transfer activities for chemical and pharmaceutical processes,Lead and ensure the implementation of CPV for new processes:
    • Definition of the initial CPV plan, creation of the initial CPV report,
    • Creation of the routine CPV plan and participation to the routine CPV committees as SME for the CPV requirements and methodology,
    • Lead complex CPV investigations,
  • Act as a Subject Matter Expert (SME) for selected topics such as Process Validation, Cleaning Validation, CPV, etc

Qualifikation

Your profile:

  • A university degree in relevant life science engineering discipline,
  • A minimum of 2-3 years of experience in a relevant field;
  • Show a pro-active, customer-oriented, results-driven, positive, can-do attitude,
  • Be problem-solving and solutions oriented,
  • Prove your ability to take sound, fast and courageous decisions and think outside the box,
  • Be a team player across different teams and different levels of the organization,
  • Fluent both in French and English,
  • Be engaged to impact patients' lives.