This is for a currently active 3rd party investigations oversight project as a component to a larger remediation program, put in place to address the Investigations/ CAPA/Change Control issues at an OTC Oral Solid Dosage manufacturing plant in the Central U.S. The site is undergoing a large and long running remediation effort and as part of this our client is being asked to provide shop floor investigations/CAPA/Change control oversight SME’s. The client is trying to avoid enforcement action in response to deficiencies which were self-reported to the FDA, but are not under WL or 483 (yet).
The role is OTC/OSD Pharma Production (i.e. shop floor) Quality Oversight, Specifically overseeing production and monitoring for deviations/CAPA/Change Management activities and intervening only when it is identified that these activities are starting to be conducted incorrectly by client personnel. The SME would oversee any unexpected condition that site personnel identify, overseeing the deviation process silently UNTIL it is observed the deviation/CAPA is not being done/conducted correctly. Then the SME would then coach and provide input (essentially take over), appropriately classifying and working the deviation/CAPA with client personnel, and reporting out on a series of predetermined metrics being collected to determine next steps and sustainable fixes.
This effort is to prevent the client from writing any further insufficient deviations/investigations/CAPA’s, while collecting data to determine changes needed to personnel/process/etc.
The resources will need to possess SME level QA/QC OTC/OSD manufacturing oversight experience with great communication skills and overall demeanor. There will also be some batch record review and retrospective Deviations/Investigations/CAPA review activities outside of the oversight.
This is ON-SITE work, with a (negotiable, but preferred) 3 weeks on and one week off rotation. SME’s will need to be available to start ASAP, with the goal of starting on-site late this week, or early next week at the latest.
The project is guaranteed for the next 4 months, but we anticipate these roles lasting for 6 or more months, followed by additional remediation.