About the role

  • Support the validation specialists during the whole lifetime of the cleaning validation to ensure compliance with Lonza procedures and regulatory guidance
  • QA Review and approval of validation documents (Soil characterization studies, risk assessments/ validation protocols and reports).
  • Support Cleaning Development teams during the development phase.
  • Review and approve Cleaning strategy paper, Swab position assessments etc
  • QA Review and approval of Annual cleaning review reports
  • Ensure the validation procedures are consistently implemented and further developed at Lonza Visp
  • Participation in audits and inspections

Requirements

  • Master degree or PhD in Chemistry/ Biotechnology or any related field
  • Significant experience in the area of biopharmaceutical manufacturing, preferably in a validation function as well as strong background in cGMP
  • Broad knowledge of manufacturing processes in GMP environment
  • Experience in interacting with all kind of interfaces within the organization as well as with regulatory agencies (Swissmedic, FDA etc.)
  • Fluency in English language required, good German language skills would be an advantage.

Benefits

  • An agile career and dynamic working culture
  • An inclusive and ethical workplace
  • Compensation programs that recognize high performance
  • A variety of benefits dependant on role and location

Job title

Senior QA Specialist, Cleaning Validation

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Postgraduate Degree

Location requirements

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