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Validating Quality Control

Thursday, February 4th, 2010
Validation Engineer Validating Medical Device Equipment

Validation Engineer Validating Medical Device Equipment

Validating Quality Control is essential for products being manufactured under extremely highly tolerances and to demanding Quality standards such as those found with medical device and pharmaceutical manufacture.

Validation is a quality control process that measures and tests against requirements that a system, product or service is achieving what it is required to do. For instance in manufacturing it is a process of zeroing equipment or plant to the exact parameters it must operate to, to produce product to an exact standard inorder to achieve a stated and fixed end result within fixed specifications outside of which it is not acceptable.

In essence it is  the process of fitness of purpose testing with the end user or other stake holders.

In many circumstances in manufacturing it can involve either computers, (hardware and software), equipment or an entire operating process or facility.

Validation in short can be explained by the question, “are you building the right thing?” and often requires reference to the Users Requirement Specifications or URS and the validation process can require a set of stringent protocols to achive completion referred to by the following terminology, IQ (Installation Qualification/OQ(Operational Qualification/Performance Qualification 

Opportunities  in Science jobs in Ireland today include positions for Validation Engineers, Validation Managers and Validation Document Control for a variety of industries and are readily found in high spec environments such as Biopharma, Pharmaceuticals, Semiconductors and Medical Device Manufacturing and are amongst some of the most highly paid science and engineering occupations availlable despite the current economic conditions.