Hi, This is Bingi from Sriveninfosys Inc....We have hot requirements on Global QA and Compliance please send me the updated resume of your consultant ASAP.
Please reply me at: [email protected] Must be Local to NJ Need Face-to-Face interview, after initial phone screen Position : Global QA and Compliance Location : Summit, NJ Duration : 3 - 6 Months Position Description: Work with clients to understand and define business objectives, user requirements, workflow requirements, and measures of success for projects. Develop solutions and key deliverables using tools and techniques such as system architecture blueprints, usability studies, etc. The senior business architect role will partner with the executive business program sponsor and leadership team to gain a detailed understanding of global QA and Compliance process, calling on their IT application expertise to identify or verify requirements and manage the technology identification and phased implementation process. Business Units Involved: - Annual Product Review - Audits (Regulatory Compliance, Clinical, etc.) - Change Control - CCT, Clinical Quality Assurance, IT, Manufacturing, and Metrology - Complaints - Corrective Action Prevention Action (CAPA) - Deviations - Regulatory Information Management - Training - Investigations - Document Management Responsibilities: Manage project team members (including vendors) and all interactions with business, IT and related functions to determine requirements and workflows to satisfy an integrated Pharmaceutical QA/QC system. Assist in defining project objectives, plan project budgets, schedules and priorities, articulate and effectively communicate project issues and status to project team members, stakeholders and executive management. Particular attention must be paid to the entire SDLC from requirements definition through specifications, implementation, and qualification. Coordinate the activities of requirements gathering and workflow definitions. Act as subject matter expert and technical resource to global QA and Compliance executive management and the IT development staff in all phases of the development and implementation process. Be ready to build and lead a team of internal subject matter experts, outside consultants and system integrators. Qualifications (minimum): Technical expertise is required in global QA and Compliance process design, planning and applying IT solutions to the quality management business function in the pharmaceutical industry. Full technical knowledge of systems analysis Bachelor degree in a Physical or Computer Science or chemistry or a related discipline with an advanced degree preferred. 7-10 years of solid, diverse work experience in a large-scale deployment of QA and Compliance systems at a bio/pharmaceutical company including business process harmonization. Experience with Computer Systems Validation, Systems Development Lifecycle, cGMP requirements and Manufacturing is strongly desired. Technical expertise in the following areas: *Applicable industry regulations such as 21 CFR Part 11 for electronic records and electronic signatures. *System architecture and design. *Validation, Installation and troubleshooting. *Business system project management experience. *Process design *Excellent communication skills, analytical ability, strong judgment and management skills. Must possess the following project management/business analyst skills: .Ability to translate business requirements. .Ability to develop use case scenarios. .Strong analytical skills. (Understanding of systems and technical design). .Ability to assess vendors and software. .Ability to apply industry trends and metrics. .Strong understanding of life cycle planning. .Data modeling skills. Ability to map business processes. .Gap analysis skills. (Understanding of cross-functional processes). .Understanding of business area operations and processes. .Methodology development. .Ability to identify and mitigate risks. · Thorough understanding of good documentation practices required for GxP compliance · Ability to coordinate cross-functional teams across global operations · Exposure to international quality regulations and compliance issues that pertain to the pharmaceutical industry Good negotiating and people skills and a good knowledge of global QA and Compliance systems and issues, so as to facilitate timely decision-making. Ability to work effectively with client and IT management and staff. The successful candidate will interact with management across identified business units and key contributors to gain alignment on business process and critical functionality for technology selection. Position will have considerable high level management exposure thus the candidate must have experience in managing executive stakeholders from across the enterprise. Thanks & Regards Bingi Technical Recruiter Sriven Infosys INC Voice : 212-999-6251 Ext: 221 Alt : 646-644-2894 Fax :212-658-9460 [email protected] www.sriveninfosys.com Sriven Infosys Inc is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, ancestry, citizenship, disability, age, military or veteran status, and other characteristics We help our clients, employees & partners compete and win! ************************************************************************************************************************* If wanted to be Removed,Plz reply in the subject line "Remove". 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