Review of all laboratory related documents in the Quality Control Laboratory e.g: finished products, bulk, raw material and stability study products as per GMP requirements in a timely manner as per the agreed timelines.
Review accuracy of data entries in raw data and chromatographic data management systems prior to release of the CoA in eLIMS.
To ensure data integrity is maintained in all the process.
Complete all training assignments and maintain personal training records.
Participate in and/or lead Out of specifications Investigations OOS.
Complete Corrective and Preventive Actions (CAPA’s).
Participate in Internal, Customer and Regulatory Audits.
Assist laboratory personnel with documentation issues and provides coaching and guidance to Quality Control team.
Provide support for Regulatory Inspections.
Identifies and implements key process improvements to areas to enhance systems, gain site efficiencies and elevate GMP requirements.
Notifies department supervisor/manager regarding omissions, incomplete testing results or other irregularities.
Ensures the test methods, protocols and Standard Operating Procedures (SOPs) have been followed by the scientists/chemists during the testing.
May be essential to perform alternating or rotating shift work (as required).
Follows up with analysts/technicians to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices standards.
Audits calibration related documents and other QC documents;