BCTG’s direct Life Science’s client is looking for a QMS-Master Control Systems Analyst / Lead to lead the implementation of a new Quality Mgt. System implementation.
- 3-8+ years’ experience in a Quality environment using with exhibited knowledge and proficiency of requirements for implementing, validating, and maintaining a QMS-MasterControl within GMP regulated field
- Attention to detail and organization of tasks and work loads
- Excellent communication skills in writing, listening, and responding with feedback
- Working knowledge of applicable GxP regulations, particularly GAMP5, 21 CFR Part 11, Annex 11, PIC/s Annex 11, and current guidance on Data Integrity and computer systems
- Proficiency in Microsoft Office (Word, Excel, PowerPoint)
- Knowledge in all aspects of GxP regulations (e.g. quality systems, root cause analysis and Total Quality Management) preferred. Including International regulations
- Experience in a computer systems validation or quality assurance role