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 "mainframe" group. To unsubscribe from this group and stop receiving emails from it, send an email to mainframe+unsubscr...@googlegroups.com. To post to this group, send email to mainframe@googlegroups.com. Visit this group at https://groups.google.com/group/mainframe. For more options, visit https://groups.google.com/d/optout.
