Pharmaceutical Quality Reviewer (Validation)
Quality Reviewer (Analytical Validation)
Our client is a contract development and manufacturing organization specializing in development and commercialization of cell and gene therapies. Our client is currently in the process of a laboratory build-out and is in need of a Quality Reviewer for analytical validation.
Our client is currently in the process of a laboratory build-out, ground up project. This consultant would be responsible for providing quality oversight including change controls, risk assessments and overall gap assessments for the laboratory build-out. This person will be responsible for reviewing validation documents (protocols, reports, final documents) from a quality standpoint. Most of the equipment and instruments are analytical; it is essential this person has worked with analytical equipment in the past. Ideally this person will have experience working with PCRs, TOC' s and other analytical equipment.
The client already has a plan in place and is waiting on the change control. This person must come from a quality engineering background and have experience supporting a facility/laboratory build-out in the past. It is essential that this person has vast knowledge of both ISO and GMP standards and regulations to ensure the laboratory is FDA compliant as a commercial testing lab. This person must have laboratory experience and have experience working with analytical equipment and instruments.
Analytical validation knowledge
Facility Build-out experience