Title:  Manager - 1

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