Job Description
Review of Extractable Leachable Protocols and Reports for all Regulatory submissions for
different dosage forms and provide/discuss comments with cross functional team.
Review of E&L Protocols/ Reports with respect to compliance to regulatory guidelines, Identifying the critical
gaps, reviewing and finalizing the tox. assessment for leachables above AET.
To file high-quality reports that would help to avoid major queries on E&L and facilitate faster
approvals so as to meet management expectations.
Work very closely cross functional teams to ensure Quality and timely availability of E&L reports,
Tox. assessment (as applicable) for quality submissions
Qualifications
M. Pharm
About Us
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
