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Sartorius Stedim India Pvt. Ltd Hiring Project Coordinator Validation Services Apply Now

For Sartorius Stedim India Pvt. Ltd. we are looking for Project / Program Coordinator to join our team in Bangalore. In this role, you will be responsible for Coordination of Bioprocess Validation Projects with a focus on filter validation for the local market based on customer and regulatory requirements while ensuring close involvement of customers and internal stakeholders. Sartorius Confidence® Validation Services provides services to customers in the (bio)pharmaceutical industry with focus on validation of filter and single-use applications.

What you will accomplish together with us:

• Understand customer requirements and concerns.
• Coordination of validation projects on behalf of customers in a timely manner according to the agreed test scenario as well as in compliance with regulatory requirements (e.g. FDA, EMA, WHO).
• Preparation of quotes for different test scenarios / scopes.
• Customer visits and travel as and when necessary (e.g. acquiring new projects, presentation of Validation Services, generating validation leads) (less than 10%)
• Ensure efficient and effective completion of validation projects under consideration of complexity and time in coordination with the sales team, the customer and the validation lab(s).
• Preparation, review and approval (based on necessity) of scientific and technical validation documents (statements, protocols, reports and other documents) in English.
• Track all validation leads and projects via applicable tools and provide monthly summary report.

What will convince us:

• Masters degree or above in biotechnology, microbiology, chemistry or equivalent
• Minimum 2-5 years experience in Validation Services, Filtration or life science industry.
• Knowledge on microbiological aspects
• Familiar with concept of GMP and GDP (Good Documentation Practices)
• Knowledge on the concept of Extractables / Leachables and related analytical methods, e.g. HPLC-UV, GC-MS, LC-MS is a plus.
• Understanding of drug manufacturing processes and pharmaceutical industry regulatory requirements ( FDA, EMA, WHO etc.) is a plus.
• Excellent interpersonal skills and ability to work in Global environment.

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