Job Description

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

Skills Required