Qualification and Cleaning Validation Specialist (limited) 100% - Fribourg

Vifor Pharma — Fribourg
15.09. | Temporary | 100%

Qualification and Cleaning Validation Specialist (limited) 100% - Fribourg

We are looking for a Qualification and Cleaning Validation Specialist to support our team in Fribourg for a period of 18 months. At this position, you work within the Quality Assurance department in close collaboration with Manufacturing, Engineering and Laboratory to manage qualification and cleaning validation of existing equipment and new equipment. Your main activities are:

  • Design and develop cleaning procedures for new products and manufacturing equipment
  • Lead and perform risk assessments for determination of worst case, critical cleaning parameters and acceptance criteria
  • Review cleaning related method validations including specific and non-specific analytical methods and recovery studies as applicable 
  • Develop technical and manufacturing documents (plans, protocols, reports) necessary for cleaning validation in alignment with corporate standards 
  • Execute cleaning validation protocols (rinsing water, swabs, contact plates)
  • Provide technical support to cleaning activities associated with the manufacturing process
  • Performs successful and on time resolution of deviations related to cleaning exercises
  • Issue Change Controls required for the implementation of cleaning procedure changes 
  • Train manufacturing and QC/QA personnel on cleaning documentation
  • Support the periodic review of equipment and cleaning validation methodologies
  • Review commissioning and qualification documents for utility, facility and process equipment (URS, FAT /SAT, IQ /OQ /PQ…)

For this challenge, we are searching for a dynamic, rigorous and social person bringing the following profile:

  • University degree in engineering or sciences area like chemistry, pharmacy, or similar
  • Minimum of 2 years of professional experiences in cleaning validation in the pharmaceutical industries
  • Previous experience in Equipment /Facility /Utilities Qualification in GMP environment
  • Fluent in French and good knowledge in English

You are a pragmatic person who likes to identify and solve problems from the roots. Responsible and methodical, you enjoy taking initiatives and demonstrate a rigorous approach to document and file management, with high attention to details. You have excellent organizational skills and prioritize according to needs. You are an open communicator with good interpersonal skills, who is able to build good working relationships with colleagues.

15.09.2020
Employee, 100%

Contact

Vifor Pharma

Brice Muller

Phone: '+41 58 851 81 24

Fax: +41 58 851 80 03


Vifor Pharma

Flughofstrasse 61Glattbrugg

Industry

Biotechnology / Chemistry / Pharmaceutical

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