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Project Coordinator Validation Services

4 months ago

Bengaluru, India Sartorius Full time

**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.