Quality Assurance Senior Specialist / In-Process Control

Job Role : 

• Ensure the implementation of quality assurance procedures, in-process and finished product inspections, complying with EVA Cosmetics best practices and approved quality standards.

Job duties & Responsibilities:

• 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 filling and packaging 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)
• Sampling and revising all produced batches on filling & packaging 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 filling and packaging area.
• Testing all filling machine parts after washing process.
• 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 filling and
• Packaging area.
• 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.
• Ensure sampling process of finished products for each batch to obtain representative samples and receiving samples to microbiology dept.
• Revising all bulk closeouts before going to the semi-finished warehouse again.
• 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.

Job Requirements

• Education: BSc. in Science or Pharmacy.
• Language: Very good English Language.
• Computer: Very good Computer skills proficiency. 

Years of Experience:  2 - 5 years’ experience within the area of Cosmetics /Pharmaceutical QA dept

 

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