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CQV Engineer

CQV Engineer

  • Location

    Springe, Germany

  • Sector:

    Quality & Validation

  • Job type:

    Permanent

  • Salary:

    90K Euros

  • Contact:

    Joe Lane

  • Contact email:

    joe.lane@catalystcareers.com

  • Job ref:

    61460

  • Published:

    17 days ago

  • Expiry date:

    2020-10-22

  • Consultant:

    #

Vacancy Details

My client, a privately owned global pharma are looking for a CQV Engineer.

Title: Qualification and Validation Engineer  

Salary: Competitive

Location: Lower Saxony  

Responsibilities:

  • Optimization of the system qualifications & cleaning validations with regard to official requirements especially FDA
  • Participation in the planning & evaluation of process performance qualifications (PPQ)
  • Project planning for changes and extensions to the production area
  • Examination and harmonization of qualification and validation concepts with regard to FDA requirements
  • Drafting the relevant documents (plans, reports, SOPs, etc.)
  • Participation in answering inquiries from authorities and participating in audits and inspections

your qualification

  • Study of engineering or natural sciences
  • Several years of professional experience in an FDA-regulated pharmaceutical company (focus: qualification / validation, Production or quality assurance)
  • Very good knowledge of relevant standards & laws (GMP and FDA)
  • Secure IT skills (MS Office, MS Project, MS Visio)
  • very good knowledge of English
  • Structured & precise way of working as well as organizational & communication skills

 

Looking but this isn’t the right position for you?

If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV to joe.lane@catalystcareers.com or call +496995179960 for a confidential discussion about potential opportunities.