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Process Validation Expert - Biotech Products
Eingestellt von Michael Bailey Associates - Zurich
Gesuchte Skills: Engineering, Support
Projektbeschreibung
PROCESS VALIDATION EXPERT - BIOTECH WE ARE LOOKING FOR A VALIDATION PROCESS EXPERT FOR 6 MONTHS CONTRACT, TO SUPPORT A PROJECT IN A BIOTECHNOLOGY AREA. THE POSITION IS FULL TIME AND BASED ON SITE IN BASEL.
THE VALIDATION EXPERT WILL RESPONSIBLE FOR IMPLEMENTING KEY ELEMENTS OF PROCESS VALIDATION TO MEET CGMP REQUIREMENTS ON TIME, AND WITH THE RIGHT QUALITY TO ENSURE THAT PROGRAMS ARE COMPLIANT WITH INSPECTION AGENCIES REQUIREMENTS AND RELATED SOPS.
Tasks required:
Author process validation protocols and reports for biotech processes (USP and DSP).
Review and interpret risk assessments for validation.
Translate the critical process parameters and the process control strategy into a focused validation plan for process validation.
Analyze and evaluate data form executed validation studies and write submission ready validation reports.
Prerequisites:
Thorough understanding of biotech manufacturing processes and related process equipment (USP and DSP).
Experience in process validation.
Expertise in reviewing and writing technical reports.
Languages:
English, German
Education (minimum):
BSc. in Chemistry, Pharmacy, (Bio-)Chemical Engineering or Pharmaceutical Technology.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
THE VALIDATION EXPERT WILL RESPONSIBLE FOR IMPLEMENTING KEY ELEMENTS OF PROCESS VALIDATION TO MEET CGMP REQUIREMENTS ON TIME, AND WITH THE RIGHT QUALITY TO ENSURE THAT PROGRAMS ARE COMPLIANT WITH INSPECTION AGENCIES REQUIREMENTS AND RELATED SOPS.
Tasks required:
Author process validation protocols and reports for biotech processes (USP and DSP).
Review and interpret risk assessments for validation.
Translate the critical process parameters and the process control strategy into a focused validation plan for process validation.
Analyze and evaluate data form executed validation studies and write submission ready validation reports.
Prerequisites:
Thorough understanding of biotech manufacturing processes and related process equipment (USP and DSP).
Experience in process validation.
Expertise in reviewing and writing technical reports.
Languages:
English, German
Education (minimum):
BSc. in Chemistry, Pharmacy, (Bio-)Chemical Engineering or Pharmaceutical Technology.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges