Sartorius Project Specialist Validation Services Graduate in Analytical Chemistry / Biotechnology or equivalent
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
Track validation leads and projects via different tools and
provide summary report as needed
Proactively participate in continuous improvement activities,
e.g. optimization of document templates or process flow as necessary
Regulatory Affairs Support
Articulate to customers and in projects the regulatory
framework as relevant to both the customer’s milestones as well as the
respective Sartorius Stedim technologies. Formulate and execute action plan of
how Sartorius Stedim technologies and services can help achieve the customer’s
or the project’s regulatory goals.
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
Skills:
Excellent written and verbal communication skills in English
Strong organizational and problem-solving skills
Team-oriented, engaging and open-minded communication skill
Customer and service-oriented attitude
self-sufficient, target oriented and self-motivated work
style with a positive attitude towards change and continuous improvement
excellent Knowledge of Microsoft Office Applications (e.g.
Excel, Word, PowerPoint)
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