Validation & Qualification Specialist - Pharma - North Germany
- Employer
- NonStop Consulting
- Location
- Hannover (30165)
- Salary
- €60000 - €70000 per annum
- Closing date
- Oct 16, 2020
View more
- Sector
- Science, Life Sciences, Cell and Molecular Biology
- Contract Type
- Employee
- Hours
- Full Time
- Organization Type
- Corporate
Job Details
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 **
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.
Company
Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries.
Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery. Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.
The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors.
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