1 year contract *West Point PA, PA * - A minimum Bachelor's degree in a science or technology discipline - 8+ years of industry experience including computer system validation, SDLC, Validation, and/or QA experience. - Experience working in a Pharmaceutical environment in a regulated (GxP) environment - High level of expertise in computer system validation regulations including 21 CFR Part 11, Part 58, Part 210, Part 211 and Part 820 is required. Knowledge of the EU Annex 11 regulations is preferred. - High level of expertise in SDLC methodology (e.g., waterfall, agile, spiral) including change management - Excellent written and communication skills including thorough knowledge of Good Documentation Practices - High level of experience in managing and conducting change control, validation planning and summarization - High level of experience writing Quality Assurance or Validation Plans and Summaries as well as change plans and change summaries - High level of experience providing guidance for adherence to SDLC and corporate and regulatory procedures. - High level of experience in ITIL change management and SOPs supporting this process - Previous experience with Remedy or comparable tool for asset and change management - Experience with software such as document management and automated testing tools (e.g., First Docs (Documentum), Client Quality Center/Application Lifecycle Management). - Ability to prioritize and manage multiple projects / efforts concurrently. - Excellent interpersonal skills including ability to work as a team member in a collaborative environment with minimal supervision. - High attention to detail.
Regards, Nimra Nayyab Technical Recruiter FAAZ Consulting LLC nimra.nay...@faazconsulting.com www.faazconsulting.com Please maintain correspondence electronically- based on the number of phone call inquiries we receive for every positing it is preferred to send inquiries via email. It may not be possible to give feedback on every resume we receive. If your consultant may be a good fit, I would personally reach out to you.We thank each one of you for helping out and being patient. *P*Please consider the environment before printing this e-mail! We at FAAZ Group deal with direct client requirements only. If you have such requirements please add us to your distribution list. If you no longer wish to receive messages from us kindly mail us with the subject REMOVE. We apologize for any inconvenience caused. -- You received this message because you are subscribed to the Google Groups "SAP or Oracle Financials" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-or-oracle-financials+unsubscr...@googlegroups.com. To post to this group, send email to firstname.lastname@example.org. Visit this group at http://groups.google.com/group/sap-or-oracle-financials. For more options, visit https://groups.google.com/d/optout.