Compliance Specialist (Pharmaceutical, 21CFR11/ EU GMP Annex 11 and GAMP 5 standards, Data integrity & CSV experience are required)

New Brunswick, NJ – Job Title Compliance Specialist Location New Brunswick, NJ Duration 6 months initial (potential extension or right to hire) bull Managing and coordinating activities related to cGMP Enterprise Electronic Systems. Duties include leading, developing, and maintaining compliance activities across IT Enterprise Services supported regulated GPS applications. Responsible for developing policies and procedures and coordinating all activities relevant between the Quality departments, IT validation and information technology in relation to implementation, maintenance and change control of computerized systems. A key focus of this role will be to provide qualitycompliance oversight to all computer system validation related activities across the GPS enterprise. The manager will guide the staff to ensure a comprehensive System Development Lifecycle Methodology in alignment with GAMP 5 requirements.. bull This role will also provide support services and governance to all supporting IT areas (GPS cor…

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