GMP & QA Outsourcing solutions
There are several situations when a facility can benefit from the engagement of outsourced human resources rather than employing a full time equivalent. For example, there may be a situation where a QA Manager needs a long vacational leave period, or perhaps is going out on maternity / paternity leave. There could also be the situation that although the work load has increased, it does not as yet justify the employment of a full time employee. Another situation could be that the workload has increased but is known to decrease in a defined time due to a particular project. These situations are just some examples where our outsourcing solutions can be of benefit to your business.
We can offer experienced professionals to fulfill the following typical outsourcing needs:
Interim Quality Assurance Managers
If you are planning for a period of time when the current QA Manager will not be available to fulfill his / her duties we can fill the gap. Contact us in advance of the planned absence since in order to fulfill the duties in a seamless manner, the allocated professional will need to be trained and get familiar with your current quality systems. We will work closely with the QA Manager so that there will also be a proper hand over of pending and important issues both pre and post contract.
Contract Qualified Person ( Commercial and IMPs)
Our team includes professionals who are registered qualified persons with the Maltese Medicines Authority and can release both commercial as well as Investigational Medicinal products (IMP's) for clinical studies. It is very important to note that this service is subject to the acceptance of the concerned regulatory body for the assigned professional to be listed as a releasing QP on the facility's licence.
Contract Responsible Person
Good Distribution Practices are becoming more and more regularized as recent revisions of the relevant guideline has demonstrated. Our experts can fulfill the role of responsible person and take care of compliance to applicable GDP guidelines.
Our experts can help you with writing reports, standard operating procedures, site master file, investigation reports, validation reports and similar technical documents.
Contact Us to ask for a quotation or if you would like to know more about our outsourcing solutions.