Job Title: VP Quality Assurance
Type of Company: I work for a global pharmaceutical company based in Michigan
Education: BS in Chemical engineering - BGU MBA, Boston University
Previous Experience: Process engineer in engineering company R&D team leader in pesticides company QA manager in pharmaceutical company
Job Tasks: I'm responsible for the quality of the drugs that the company is producing. I help the company to pass the Food & Drug Administration inspection and to make sure that no harm will be caused by the drugs the company is producing. I'm also responsible for the Quality control laboratory that is testing the drugs produced by the company to make sure they are produced as expected. In my department there is a documentation center. All the documents of the company such as batch records of the drugs produced are kept in the center.
If a customer want to complaint about a drug my team investigate the complaint and take care of the corrective & preventive actions if needed. I'm conducting all the audits of the suppliers of starting materials. It means that I visit the starting material production site for few days and check the quality level of the site and the materials produced. If a production site is not passing the audit our company is not able to purchase any starting materials from this supplier.
From time to time our company receive auditors representing the customers of the drugs we produce. I'm responsible to manage the inspection and to show the inspectors (auditors) all they want to see in the company including the production plant, all documents related to production. the quality control laboratory and all documents related to testing of the drugs.
Best and Worst Parts of the Job: Best part is the fact that I'm personally responsible for the wellbeing and health of the people that are taking the drugs manufactured by our company. The worst parts is that if I make any mistake and release a drug that is not safe for use someone can get sick or even die
1. You need to read and learn as much as you can about Good Manufacturing Practice
2. You need to always pay attention to all small details and be very organized.
3. You should earn your Bsc in chemical engineering or in chemistry or biology. It will help you to understand better the terminology used.
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