Senior Peer Reviewer

Peer Reviewer III

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 within 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.

Qualifications

Education:

• Bachelors Degree (BA/BS) - Required

Experience:

• 6 years or more in scientist or group leader in pharmaceutical lab

Required Skills

• Analytical Chemistry
• Biochemical Assays
• Chromatography
• Continuous Improvement Process
• Decision Making
• Detail Oriented
• Experimentation
• Good Manufacturing Practices
• Innovation
• New Product Development
• Process Validation
• Quality By Design (QbD)
• Troubleshooting (Problem Solving)