QA Inspector
Dammam Pharma (SPIMACO)
Total years of experience :3 years, 2 Months
Comprehend, maintain, and promote cGMP and SOP compliance as per SFDA regulated manufacturing environment, ensuring product integrity, safety, and compliance with standards.
Ensuring that manufactured items are made and assemble correctly according to Governorate standards, safety regulations and customer’s satisfaction.
Follow up the check list of the RH, Temp. At the different places at the warehouse.
Inspection on the destruction process for the rejected finished products, raw materials and packaging materials.
Ensuring that all activities are done under SOPs guidelines.
Inspection on the raw and packaging materials and ensure it comply with the acceptance criteria.
Inspection on the operation process at the manufacturing area, blistering area, and packaging area, and ensure that the areas are clean from any previous product and that the all machines are cleaned and ready for the new product.
Check the RH, the temp. And the pressure of all the areas according to its classification.
IPC in MFG. and PCKG. Area.
Inspection on every process according to the batch record and ensure that the line clearance process is completed between every product.
Taking the samples to the Q.C department as the Bulk, RW, Packaging, and FP, for reference and stability samples.
Review the recording of all the production steps at the batch process and the batch packaging.
Release the batch to the guarantee area after the final reconciliation. Create and revise SOPs, work instructions, and uploading it in the SAP.
Highlight deviations / change control, to establish corrective action plan, and include recording all the deviation which occurs at all the production process and writing the corrective, preventive action, risk analysis, and uploading it in the SAP.
Making internal audit.
Review batch dossier for product release to ensure right and correct implementation of transfer SOPs, to validate each product transfer.
•Managing, Coordinating, Interacting, Reviewing, and preparing all what is related to QC/QA activities in the company.
• Proactively identified and solved complex problems that impacted management and business direction.
• Created and issued Standard Operating Procedures for the team>
• Audited existing operational practices, proactively challenging, and
implementing improvement to ensure compliance and growth.
•Investigated incidents of non-conformance using effective analysis techniques.
• Measured and monitored quality performance against agreed KPI's, implementing recommendations as needed.
• Defined corrective actions for non-conforming report and complaints for continued quality improvements.
• Investigated customer complaints to address areas of improvement, eliminate non-conformance and increase customer satisfaction.
• Led auditing processes of lab operations.
• Identified corrective and preventative action for issues through complete
failure investigations and resulting.