Validation Specialist with FDA - Pharma - North Germany

Expiring today

Location
Hannover (30165)
Salary
€60000 - €70000 per annum
Posted
Sep 29, 2020
Closes
Oct 29, 2020
Ref
TC 258925 16
Contact
Triada Chalkidou
Organization Type
Corporate
Contract Type
Employee
Hours
Full Time

My client is a big pharmaceutical company located in Hannover, helping patients with life-threatening diseases.

Currently, they are using their expertise to develop treatment options for COVID-19 infections.

To enforce their team in the Production site, they are looking for a Qualification & Validation Specialist with a few years of experience on FDA and GMP standards & laws.

** PERMANENT ROLE **

Your tasks:

  • 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
  • Testing & harmonization of qualification and validation concepts with regard to FDA requirements
  • Drafting the relevant documents (plans, reports, SOPs, etc.)
  • Collaboration in answering inquiries from authorities and participating in audits and inspections

Your profile:

  • Degree in life sciences
  • 2+ 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)
  • NATIVE OR FLUENT GERMAN and very good knowledge of English
  • Structured & precise way of working as well as organizational & communication skills

If this sounds like the right opportunity for you, please apply here or send your CV to me in word format, on T.Chalkidou@nonstop-recruitment.com or call me directly on +49 892 109 3363 (internal extension 3514) for a confidential conversation.

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