Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMP)
Provide floor support for GMP activities
Monitor for GMP compliance of all in-process activities during GMP processing.
Perform AQL particle inspection of in-process product vials prior to packaging.
Gown qualified for entry into controlled manufacturing areas to perform quality functions as assigned.
Perform real time review of executed Batch Documentation and prepare for eventual disposition by QA management.
Organize documentation for Batch History Files and scan files.
Ability to search, document and generate quality event reports for Batch Release.
Assist with regulatory inspections and partner audits with management oversight.
Maintain databases as required
Strong knowledge of GMP’s and their application
Prior experience with Batch Documentation review
Ability to work proactively and cooperatively with managers and operational staff to solve quality problems
Ability to manage multiple responsibilities with a high degree of self motivation
Good written, oral and interpersonal English communication skills
Ability to use Microsoft Word and Excel applications
Source: Job Diva – Job Listing