Title:  Senior Research Scientist

Summary of Key Responsibilities:
Responsibilities include adequate and accurate review of analytical data generated for regulatory submission.
 Review documents of Validation reports, Analytical reports
 Review of data generated for regulatory filing
 Ensure data integrity through review
 Ensure adequacy of documents with respect to ICH and regulatory guidelines
 Complete documentation activities for review and approval of documents
 Audit trail review for data reviewed
 Review data in instrument applications like Empower
Minimum requirements
 3 years of previous work experience in lab or QC, Minimum 2+ years of relevant experience in
document review
 Bachelor’s /Master degree in Science
 Ability to work collaboratively in a fast-paced, high energy organization
 Report writing skill
Behavioral competencies
 Work in Team
 Communication skills
 Willingness to learn