Senior Peer Reviewer
About the role
Average of 6 years of experience in a scientist or group leader position within a pharmaceutical laboratory.
Responsibilities
- Review laboratory testing records with respect to written procedures/specifications, SOPS, and company policies.
- Review laboratory instrument calibration/qualification records, standard qualification records and records associated with investigations.
- Review raw material, excipients, finished product for data integrity, compliance with specifications, methods and USP monographs as applicable.
- Review analytical method validation/verification data for compliance with protocols and ICH guidelines.
- Review stability data to identify any trends, alert limits and OOS.
- Participate in audit of laboratory activities to determine improvement needs for maintenance of cGMP compliance.
- Prepare for pre-approval audits for filed ANDAs.
Qualifications
- Bachelor's degree in a relevant field (BA/BS).
Skills
N/A
Benefits
N/A
Pay
N/A
Schedule
N/A
Additional Information
Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at accommodations@amneal.com . Requests will be handled confidentially and in accordance with applicable laws.