GMP Support Specialist

This position supports and maintains Facilities GxP (GMP & GLP) compliance by acting as a liaison between Facilities, QC, GLP and QA. This position is responsible for preforming Facilities related incident investigations, CAPA, CAPA effectiveness, audit responses, and other Quality System activities. This position supports the change control system by managing Facilities related Change Requests (CR). This position supports equipment qualification by providing support reviewing and approving equipment qualification protocols and reports. Drafts Facilities SOPs and work practices. Responsibilities: Facilities Deviation and CAPA department representative Facilities Change Control Coordinator; represent facilities at Change Control meetings; initiating and managing Change request paperwork Lead and manage Facilities Change Requests (CR) Support audit host and lead auditors System Administrators for validated computer systems (EMS & BMRAM) Lead continuous improvement efforts Qualifications: Must have a minimum of 3-5 years experience leading deviation investigations, CAPA and participating in audits and responding to audit observations Previous experience working in a regulated biotech, pharmaceutical or health care industry required. Must have demonstrated ability to effectively support operations in a GMP and/or GLP environment, preferably with the role of Facilities and Engineering

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