Our client has an upcoming FDA inspection. FDA has already been to the site and they need to respond to FDA (preferably by END OF MARCH)
Review FDA response letter and perform a very thorough mock inspection of facility. Answer questions and be client facing. They have 3 end clients.
Not looking to make any radical changes and this consultant needs to “respect their process”
Not looking for a delegator but someone who can provide oversight and training to a very young site. Roll up sleeves and formulate a strategy that will satisfy FDA response letter.
Client is paper based – they are working on getting a Trackwise system in place and currently use LIMS for inventory and batch books.
Required Skills/ Experience
Exp. with Radio Pharmaceuticals is a huge plus and highly desired. Will take heavy Biologics background too
Houston TX: Sr. Quality Assurance Consultant (232849)