• Promote conformance to GMP's regulations, data integrity, GDP regulations.
• Ensure compliance with Company Standard Operating Procedures (SOPs), policies and procedures, including safety rules, authority regulations and guidelines.
• Ensure compliance with environmental conditions (room temperature – ?P requirements - humidity), machine cleaning & verification, calibration & verification checks
• Record every CPP & CQA of bulk product and reporting of unusual incidents.
• Reviewing raw material weights and validity.
• Ensure that the needed IPC & bulk samples are taken as per the sampling scheme.
• Cooperate with validation team during the process validation and the scale up of new product.
• Ensure of recording all deviation and out of control cases which are related to the mixing area and assist in root cause analysis.
• Remain current with all pertinent standard operating procedures relating to batch record review and QA system.
• Assure full preparedness for manufacturing