QA Specialist-(In process control)

Job Description

• Promote conformance to GMP's and FDA regulations.
• Evaluate addressed deficiencies for potential impact on compliance status while working with all concerned departments to correct any noted deficiencies/inconsistencies.
• Ensure compliance with current Good Manufacturing Practices (cGMP), Company Standard Operating Procedures (SOPs), and authority regulations and guidelines.
• Ensure compliance with all Company policies and procedures, including safety rules and regulations.
• Proper application of line clearance from the previous products.
• Perform checking conformance to G.M.P& FDA regulation (room temperature-Magnehelic reading - humidity– Cleaning concept – Gowning process).
• Monitor the environment of production areas.
• Ensure calibration and validity calibration for balances.
• Ensure the presence of the batch record which indicate the whole history for products
• Record every CPP & CQA of finished product and reporting of unusual incidents.
• Revising inkjet and embossing data.
• Make sure of welding of the tube and occurrence of burst test for tubes.
• Make sure of presence of all SOPs related to the production area (machines- gowning- washing process- personal hygiene – personal knowledge for workers)
• Revising all produced batches on production lines.
• Reviewing the bulk product barrels to be sure from its conformity with the reference samples.
• Make sure of presence of reference standard sample to be weighed.
• Make sure from the conformity of the finished product with the reference sample (Product name- conform design – printed data – primary and secondary pack- color- homogeneity- odor).
• Attending all new products trials in production areas.
• Observe conditions on line and in-process area for compliance with the process method for correct operation of procedures and for cleanliness and clearance of other components.
• Ensure of recording all deviation and out of control cases which related to the production areas.
• Make sure of corrective action taken in deviation process.
• Revising and checking reference samples of finished products for each batch to obtain representative samples which conform with standard samples from 1st ,2nd and 3rd of line.
• Examine the damaged materials well and make sure that they are not suitable for filling again.
• Examine the supplier defect before returning to the warehouse.
• Contact with concerned department when there’s problem with bulk or packaging material.