*Hi*
My name is Archana and I am recruiter at Sage Technologies. Sage Technologies is a global contingency staffing firm servicing fortune 1000 clients globally. We have an excellent job opportunity with one of our client. *Title: CSV(**Computer sysyem validation)** Lead* * Location: Somerset, NJ * *Duration: 3-6 months Interview: Phone & Face to Face * * USC, GC & EAD only* *DESCRIPTION : * *Job Duties:* • Develop a plan for the validation of computer and automation systems ensuring compliance to required regulatory requirements. • Partner with the Global IT Compliance organization to gain in-depth understanding of guidelines, requirements and general expectations related to Computer Systems Validation and Compliance • Deliver validation activities in compliance with US and EU regulations. • Participate in the design of systems and equipment, if needed, to ensure that they comply with GMP/GCP/GLP requirements. • Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports. • Initiate and implement change control activities in accordance with site procedures. • Compile and analyze validation data and make recommendations for improvements. • Participate on cross-functional project teams with the support of Validation activities. Leadership Responsibilities: • Manage a team of CSV contractors in the development and execution of all validation documentation specific to the defined application development (Project ) consistent with Clients' SDLC and IT Compliance standards • Give guidance on all activities related to computer and automation system validation. • Prepare and deliver regular updates and communications (verbal and written) to the team and extended business partners regarding the progress of the Validation work stream. • Review and approve documents prepared by the validation team, other departments and contractors (e.g. test plans, impact assessments, change controls, etc.). • Contribute directly to the completion of projects through the management of assigned contract personnel, if applicable. • Coordinates and executes training of required personnel on the computer and automation systems validation procedures and methodology. • Prioritize qualification activities in line with the project schedule. Day to Day Technical Responsibilities: • Author relevant validation documentation (e.g. Master Plans, Test Scripts, Templates, etc.), as defined by the Client's IT SDLC methodology. • Execute all relevant validation protocols and test procedures, as defined by the Clients' IT SDLC methodology • Develop validation documentation as required (e.g. specifications, user requirements, plans, protocols, procedures, traceability matrix, error/defect reports, etc. ). • Execute qualification protocols as required. • Prepare reports of executed protocols for review by QA. • Track and resolve exceptions during qualification activities. • Proactively resolve conflicts between compliance requirements and project/business constraints. • Co-ordinate validation activities with IT, Business, QA activities. *Skills and Experience Required:* *Mandatory Requirements:* • 10+ Years: Computer System Validation • 6-8+ Years: BIO/Pharmaceutical industry experience • 5+ Years: Demonstrated leadership in SDLC/CSV, IT Compliance and/or IT Quality Assurance • Experience with Managing/Training Offshore resources. • Experience with equipment controlled by ERP, LIMS, EMS, PMS, and other Quality and Development Laboratory systems. • Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11, and GAMP standards are required. • Root cause analysis; experience investigating and troubleshooting automation and control systems • Strong leadership skills and the ability to work in cross-functional team environments, as well as independently, and to manage multiple and competing projects are required. • Strong written and verbal communication skills • Knowledge of MS Office, SharePoint, MS Project, and Visio. *Desired Requirements:* *• *Knowledge/familiarity with U.S. and Global regulatory registration of drug products is preferred. • International, cross culture, and cross functional experience desired • Project management skills *SKILL MATRIX * *Total IT * *Experience with Computer System Validation* *Experience with BIO/Pharmaceutical industry* *Experience in LeaderShip Role:* *Experience with Demonstrated leadership in SDLC/CSV, IT Compliance and/or IT Quality Assurance* *Experience with Managing/Training Offshore resources* *Experience with equipment controlled by ERP, LIMS, EMS, PMS, and other Quality and Development Laboratory systems* *Experience with cGMP regulations related to CSV including 21 CFR Part 11, and GAMP standards are required* *Experience in investigating and troubleshooting automation and control systems* *Highest Education* *Thanks & Regards,* *Archana* *Technical Recruiter* *Sage Group Technologies Inc. * *www.sagegroupinc.com* <http://www.sagegroupinc.com/> 3400 Highway 35, Suite # 9, Hazlet, NJ 07730 *W: 732-767-0010 x 227 | D: 732-658-5828* *Email: agau...@sagetl.com <agau...@sagetl.com>* -- You received this message because you are subscribed to the Google Groups "Citrix and Sap problems" group. 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