Senior Peer Reviewer

Description:

Peer Reviewer III is responsible for reviewing and approving data that is generated by the laboratory to ensure accuracy and compliance with procedures and cGMP requirements. Complete audit tasks withing specified time frame without compromising quality of audit. Continuously improve the documentation system to increase efficiency and GLP compliance. Report all audit findings in audit reports and highlights as well as report any critical deficiencies.

Essential Functions:

* 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

* Participation in audit of laboratory activities to determine improvement needs for maintenance of cGMP compliance

* Prepare for Pre-Approval Audits for Filed ANDAs

Additional Responsibilities:

* Perform other duties as assigned.