Description
On behalf of my client, an international pharmaceutical company with headquarters in Basel area, Switzerland I am looking for:Validation Expert 100% m/f
The validation expert for bio-tech products is 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.
Job description:
- Author process validation protocols and reports for bio-tech 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.
- Analyse and evaluate data form executed validation studies and write submission ready validation reports
Required skills:
- Thorough understanding of bio-tech manufacturing processes and related process equipment (USP and DSP)
- Experience in process validation
- Expertise in reviewing and writing technical reports
- BSc. in Chemistry, Pharmacy, (Bio-)Chemical Engineering or Pharmaceutical Technology
- Fluent in German and English
Duration:
6+ months, big chance for an extension
For extra information's please don't hesitate to contact me directly on or
Looking froward for a successful collaboration!