Sartorius Project Specialist Job Vacancy - Chemistry

Sartorius Project Specialist Job Vacancy – Chemistry

Better health for more people: As a leading partner of the biopharmaceutical and research sectors, we are committed to this ambition through our innovative products and services. Want to join Sartorius, chemistry candidates may apply for the Project Specialist post. Check out all the details on the same below:

Job Title: Project Specialist Validation Services

Qualification & Experience:

Education:

Graduate in Analytical Chemistry 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)
  • Working Conditions/Environment (work schedules, travel, etc.):
See Also
IIT BHU Pharma Research Fellow Job - Applications Invited

Essential Responsibilities :

Validation Services Sales Support

  • Promote Validation Services to the local market (workshops, webinars, etc.)
  • Support consumables business growth via cooperation with sales colleagues and application specialists
  • Visit customers to support the acquisition of new projects, consultation on test scope and present Validation Services
  • Execute internal and external training

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

See Also
IIT Gandhinagar PhD Chemistry Job Opening - Application Details

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.

The job demands the candidate to be willing and able to travel (up to 30-40%)

Interested? Driving our future growth requires talented people. Sartorius is a dynamic organisation suited to people who want to showcase skills, be recognised for expertise and thrive in a vibrant and innovative environment.

Apply Online

Editor’s Note: Sartorius Project Specialist Subscribe to Rasayanika for latest chemistry and Pharma job openings, Follow us on Facebook and WhatsApp for the latest updates.

Upload your CV to Rasayanika Talent Pool

LEAVE A REPLY

Please enter your comment!
Please enter your name here