Hi, please share resume only at *[email protected] <[email protected]> *
*Job Title* - Validation Lead *Location * New Jersey/Union *Duration * - 6 Months *MOI * - T+ Skype BS in Computer Engineering/Computer Science. 10+ years experience in FDA-regulated industry, 10+ years experience in computer automation/validation/administration Responsibilities include, but are not limited to, the following: 1. Manage and Execute Computer System Validation Projects supporting Lab Operations: Develop project plans and manage/execute the implementation activities of new computerized lab systems and upgrades to laboratory system software. These activities include the definition of needs, benefits, and technical strategy; research & development within the project life-cycle; technical analysis and design; and support of executing, testing and rolling-out the solutions. Very strong technical background is required with emphasis on solutions to technical and 21 Part 11compliance challenges and gap mitigation. 2. Technical Support: Provide technical input to address validation deviations, provide technical assessments for change requests, identify qualification/validation requirements to ensure GMP compliance, assist in the design, analysis and approval of IQ, OQ, PQ, and PV protocols and reports, perform SME Role for audits of software vendors, and perform technical reviews of validation deliverables. Provide technical input to address system troubleshooting and administration post system release. Must be able to learn, use, configure, administer, troubleshoot new applications with no or limited training. Must be familiar with and navigate Windows Event Viewer, Local Group Policies, Windows Registry. Must be able to understand Windows folder security and basic Windows batch script syntax. 3. Documentation: Create and Maintain Technical Support Manuals for all supported GMP and Non GMP systems. Write and review System Administration SOP’s. Supervise the creation and maintenance of knowledge objects for supported systems. Perform an assessment/audit of validation packages during validated system relocations from external sites in order to ensure all required deliverables and approvals are present as per local processes and procedures. 4. Communication: Ensure that the status of all computer systems is continually kept up to date and effectively communicated. Effectively communicate relevant IT-related information. Understand how to communicate difficult/sensitive information tactfully. Keeps track of lessons learned and shares those lessons with team members. Communicates effectively with internal clients to identify needs and evaluate alternative business solutions. Continually seeks opportunities to increase internal client satisfaction and deepen client relationships. Skills/Knowledge Required: § Computer Engineering/Computer Science § 10+ years experience in FDA-regulated industry § 10+ years experience in computer automation/validation § Strong computer system validation, administration, and troubleshooting background in a laboratory environment § Excellent knowledge of cGMP in the pharmaceutical/biotechnology industry § Excellent computer skills § Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently § Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required *Amit Kaushish | RG Talent Inc.* *Lead Recruiter* *39120 Argonaut way Suite # 157, Fremont, CA (94538)* *Gtalk - amit.rgtalent* -- You received this message because you are subscribed to the Google Groups "Oracle Developers" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at https://groups.google.com/group/oradev. For more options, visit https://groups.google.com/d/optout.
