GMP Compliance Specialist

Job Purpose

To ensure timely testing, review, and release of finished products and stability samples while maintaining compliance with cGMP, GLP, data integrity, and regulatory requirements for sterile manufacturing operations.

Key Responsibilities

• Ensure compliance with cGMP, GLP, data integrity, and regulatory guidelines.
• Plan and monitor analysis of finished products and stability samples as per priority.
• Manage sampling, distribution, and tracking of bulk, intermediate, finished product, and stability samples.
• Review Certificates of Analysis (COA) and approve analytical results in LIMS.
• Review analytical raw data, summary sheets, and trend reports for finished products and stability studies.
• Review and approve stability protocols, reports, and analytical data.
• Review analytical method validation and technology transfer protocols, reports, and supporting data.
• Review S...