Hi, I have an urgent requirement with one of my clients. Please find the job details below and forward me your updated resume along with your contact details at *skh...@tekshapers.com <mgu...@tekshapers.com>* or call me at *248-565-4747 <248-565-4747>*127*
Business Analyst with Pharma Domain Los Angeles,CA 12 months+ Phone Hire Position Overview • Manage the planning and execution of projects for local implementations within a regulated cGMP environment • Facilitate and contribute to challenging meetings & discussions with cross functional representatives which may include but not limited to Process Development and Technical Services (PDTS), Quality, Engineering, Manufacturing and local IT. • Manage the expectations of key stakeholders (i.e. balance their needs with wants and educate as appropriate). • Work collaboratively with business partners and IT business managers to assess the data requirements and propose solutions. • Ensure proper documentation is created for all projects, including and not limited to technical specifications and test cases. • Verify the solution is developed in accordance with Shire’s computer system development life-cycle procedure. • Work with a team of outsourced developers to ensure requirements are understood and priorities followed. • Ensure excellent service by interfacing with users to resolve issues and incidents as the primary or first point of contact. • Provide user training, tips and tricks, best practices or etc. on an as-needed basis. • Ensure that solutions are innovative and meet the data security, verification and validation requirements. Qualifications • Experience in Life Sciences (Biologics, Pharmaceutical or Medical Devices) manufacturing required • Minimum must have exposure and knowledge of FDA computer system validation principles • Experience working indirectly with S95 Level 2 and/or 3 systems highly preferred (e.g. LIMS, MES, Automation, PLC, BAS, etc.) • Bachelor’s Degree • 4+ years of experience in developing system applications to solve business problems • Working knowledge in using program languages (e.g., SQL, HTML) • Ability to map and translate business process or concepts into technical requirements and vice versa. • Experience in requirements definition and design specifications • Proficiency in testing methodologies using standard tools/utilities, for developing and supporting applications; • Proficiency with following a Systems Development Life Cycle (SDLC) and Agile Development Methodology when developing systems. • Experience with technologies using validated technologies (preferred) • Excellent communication (written, verbal & presentation) and meeting facilitation skills. • System integration, data warehousing, ETL and/or data modeling experience or past projects preferred. • Previous experience in GMP environment or pharmaceuticals/medical device industries preferred. • Experience working with or using various statistical applications (statistical process control, process capability, quality by design, etc.) preferred. • Ability to work collaboratively with remote team members around the world • Demonstrated experience in innovative thinking and • Demonstrated experience in pragmatic technical and project management problem solving • Goal oriented, task driven decision-making with a strong sense of accountability Regards, Saumya Khare Talent Acquisition Specialist Tekshapers Inc. 1441 E. Maple Rd, Suite # 301, Troy, MI 48083 T: 248.565.4747 | Extn. 127 | Fax: 248-254-7211 Certified: WMBE Certified | E-Verified Company | ISO 9001:2008 E: *skh...@tekshapers.com* <nve...@tekshapers.com> | W: *www.tekshapers.com* <http://www.tekshapers.com/> -- You received this message because you are subscribed to the Google Groups "SAP Resource Center" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-resource-center+unsubscr...@googlegroups.com. To post to this group, send email to sap-resource-center@googlegroups.com. Visit this group at https://groups.google.com/group/sap-resource-center. For more options, visit https://groups.google.com/d/optout.
