Ensuring all QC activities adhere to GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), and other relevant regulations.
Maintaining accurate and complete QC documentation, including test reports, logs, and records.
Participating in internal and external audits to ensure regulatory compliance.
Supporting method validation, calibration, and equipment qualification activities.
Testing and Analysis:
Performing sampling, testing, and analysis of raw materials, in-process, and finished injectable products.
Operating and maintaining laboratory instruments, such as HPLC, GC, UV, etc.
Conducting stability studies to assess the shelf life of injectable products.
Problem Solving and Improvement:
Identifying and reporting deviations from quality standards, ensuring corrective and preventive actions (CAPA) are taken.
Collaborating with production, QA, and other teams to resolve quality-related issues.
Participating in the investigation of batch failures and OOS (Out of Specification) situations.
Supporting the development and implementation of quality control systems.
Supervision and Training:
Supervising QC inspectors and ensuring they adhere to SOPs (Standard Operating Procedures).
Providing training to QC staff on relevant procedures and techniques.
Documentation and Reporting:
Preparing and maintaining test reports, logs, and other QC documentation.
Ensuring the timely completion and traceability of all testing activities.
Maintaining accurate records of all QC data and results.