Quality Validation Engineer
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I am a Quality Validation Assurance Engineer with over Eighteen years’ experience and over Thirty years in the pharmaceutical business. I have worked with various clients from Major to Small pharmaceutical companies, as well as Generic, Contract pharmaceutical manufacturing and packaging companies.
I have performed qualifications on computer systems such as ProCal Calibration and Preventive Maintenance system, ValGenesis, Veeva (Quality Management System), JD Edwards, Trackwise, and Building Automated Systems such as CIMScan, and DELTA V from beginning to end of writing protocol, executing, and writing Final Report.
My background also involves process validation of sterile filling, bottle packaging, blister packaging and serialization. Development of standard operating procedures for not only equipment but process as well. Developed cleaning qualifications to confirm the removal of drug product from equipment as to not cause cross contamination.
After determining worst case soilant taking the appropriate detergent or acid/base combination along with determined amount of water to clean the equipment. Developing a sample map for the appropriate sampling. Confirming parameters developed are suitable for production from a Quality and Safety standpoint.
I have been a part of two remediation projects due to companies receiving a Warning Letter from Regulatory Agencies, four preapproval inspections for new products to market and various launches of products that were packaged and being introduced to the market. I feel with my over thirty years in Pharmaceutical Business that I would be an asset to your company.
Over 29 years experience in Pharmaceutical business with over 18 years in Quality Validation
Bachelor's degree in Biology from Delaware Valley College
