Specialist in Validation & Qualification - North Germany
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 with blood plasma products 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 **
- Optimization of the system qualifications & cleaning validations with regard to official requirements
- 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
- 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.