Beschreibung:For one of our Pharma-clients in Hannover we are seeking freelance support as:QC Documentation Improvement Expert (M/F/D)
The overall project goal is to bring the Human Health QC department into a steady state of operation. Creation of the Human Health Department was established in late 2019 and was asked to within quick succession to not only create new process and procedures but in parallel start performing the Routine daily work.
Normally the creation of processes and procedures would be in place close to the beginning of routine production work. To allow the QC to become the fully functional department it needs to become many SOPs, Worksheets, and Job Aids will need to be created.
In addition, there is a backlog of updates needed for existing SOPs that will require ownership and assistance.
The requirement for this project is that, they will own the process of helping create, send for review (internal and other associated departments), obtain approval of the document, and ultimately have the Documents become Effective and Active within our GMP systems.
Must be able to Work with MIDAS (or equivalent GMP system for storage and approval flow of documents)
Work with Change Management system to document the updates and changes to the documents (Reliance or equivalent system).
Start: 01.11.2020 // Duration: 12 months // Capacity: full time onsite
Strong Background in Quality Assurance / Quality Control within the pharmaceutical industry
Knowledge of SOPs and Processes
Experience in Accessment of SOPs, Worksheets, Job Aids
Collaboration Skills, dealing with multiple departments/groups to push through the approval of documents