Sartorius Project
Specialist Validation Services Graduate in Analytical Chemistry / Biotechnology or equivalent Life sciences
Essential Responsibilities :
Validation Services Sales Support
Promote Validation Services to local market (workshops,
webinars, etc.)
Support consumables business growth via cooperation with
sales colleagues and application specialists
Visit customers to support acquisition of new projects,
consultation on test scope and present Validation Services
Execute internal and external trainings
Management of Validation Projects
Understand customer requirements and concerns
Coordinate validation projects for microbiological and
physico-chemical test methods including Extractables / Leachables testing on
behalf of the customer in a timely manner according to the agreed test scenario
as well as in compliance with regulatory requirements (CDSCO, FDA, EMA, WHO,
etc.)
Engage in risk assessment based on science, technical
considerations and regulatory requirements in line with Sartorius Stedim
validation philosophy and globally harmonized test methods
Prepare quotes for different test scenarios
Ensure completion of validation projects effectively under
consideration of complexity and time advised via coordination with sales team,
customer and validation lab
Prepare, review and approve scientific and technical
validation documents (statements, protocols, reports and other documents) in
English
Qualification & Experience:
Education:
Graduate in Analytical Chemistry / Biotechnology or
equivalent
Experience:
Minimum 3-5 years experience in life science industry or
contract laboratories in the field of Extractables / Leachables testing
Experience in supporting Filtration / single-use bioprocess
Validation Projects
Knowledge on the concept of Extractables / Leachables and
related analytical methods, e.g. HPLC-UV, GC-MS, LC-MS
Good understanding of drug manufacturing processes and
pharmaceutical industry regulatory requirements (CDSCO, FDA, EMA, WHO etc.)
Familiar with concept of GMP and GDP (Good Documentation
Practices)
Experienced with Project Management and Teamwork in global
environment
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