*Job Title: *Process Engineer Visa: U.S.Citizens Only
*Work Location* (State, City): St. Louis, Missouri *Duration of assignment *(in Months)*: *12 Months *Relevant Experience& Experience Required** (in Yrs): *6 -8 years experience in infrastructure qualification and GAMP 5 requirements. *Technical/Functional Skills** -MUST HAVE SKILLS* Good understanding of Software Development Life Cycle (SDLC) and Validation life cycle · Experience in formulation of as validation master plan, User Requirement Specification (URS), Functional Requirement Specification (FRS), Business Requirement Document (BRD) and Validation Protocals( IQ,PQ & OQ). *Roles & Responsibilities* This position is responsible for leading and performing activities in support GAMP v5, a risk based approach to computerized System Validation and Infrastructure Qualification. This position is also responsible for monitoring compliance industry best practices on CSV under a GxP environment. · Manages the infrastructure Qualification of Hardware/Servers/Network Devices. Ensure IT infrastructure, hardware and software systems for the regulated network are installed, perform and operate according to specifications and user requirements. · Lead qualification and validation efforts of the regulated systems/network by documenting qualification and validation requirements and reviewing all documentation used to support qualification and validation activities both pre and post qualification or validation. · Create of Installation Qualifications, Operational Qualifications and Performance Qualifications. · Provides Qualification/Validation protocol and report oversight. · Manages the overall protocol execution process, scheduling, incident management, and status reporting. Prepares Validation package per policy and procedure to support the validation of an system for Go-Live. *Pharma:* · Should be well versed with the Pharma domain – terminology & industry standards. · Should have knowledge of 21 CFR Part 11– Computer Systems Validation and other regulatory compliance processes. · Should be aware of other regulatory mandates such as FDA, HIPAA, SoX, GxP and ISO standards. -- *Regards,* *Shashank Tewari* *Mailto :- **[email protected]* <[email protected]> *Gtalk :[email protected] <[email protected]> * *Gmail :- [email protected] <[email protected]>* -- -- *************************************************************************************** For all SAP related tutorials,Articles,Faqs,Tips www.sapbrainsonline.com **************************************************************************************** You received this message because you are subscribed to the Google Groups "sapbrains" group. To post to this group, send email to [email protected] To unsubscribe from this group, send email to [email protected] For more options, visit this group at http://groups.google.com/group/sapbrains?hl=en --- You received this message because you are subscribed to the Google Groups "sapbrains" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. For more options, visit https://groups.google.com/d/optout.
