Hi,
Please find the requirement below and answer ASAP with updated resume and contact details to [EMAIL PROTECTED] ...Thanks a lot... ------------------------------------------------------------ Resumes with the following information will be given preference. Full Name: Current Location: Relocation: Availability: Work Authorization in US: Contact Number: Email: Rate on C2C: Please ensure all candidates have all skills listed under "Required Skills" in their resume. ---------------------------------------------------------------- Position: Validation Lead Address: Springfield, NJ Length: 9+ months Skills Required: Position 1: Validation with InSight Publisher product experience and Position 2: Validation with FirstDoc R&D experience. 8-12 years experience in pharmaceutical industry, project management, systems analysis and/or validation execution. Advanced educational degrees considered in work experience evaluation. Experience should include generation of all validation deliverables including SOPs for automated systems in manufacturing, lab and IT environments. Knowledge of GxPs, health authority regulations and computer validation requirements. Candidate must have ability to multi-task, strong interpersonal skills, analytical skills, compliance interpretation skills, learn quickly, the ability to effectively communicate, collaborate convince, and drive team consensus. Performs effectively within a matrix/team environment. Duties may include instructing, directing and checking the work of other team members. Requires working with members of different cultures in a global environment. Strong working knowledge of computerized and automated systems used in a GxP environment. Good project management skills. Assignment Description: Performs consistent validation and process excellence on assigned projects while demonstrating in-depth knowledge of computer system validation (CSV), equipment qualification and health authority regulations. Applies strong knowledge of computer system validation across all technology types, including application of system lifecycle methodologies and documentation requirements. Works independently and within a team, under the guidance of the Validation Unit, on CSV projects and provides guidance on validation concepts with minimal oversight. Develops validation deliverables for computer system related projects, including: System Validation Plan, Requirements Specification, Traceability Matrix, UAT Test Plan, Validation Summary Report Works collaboratively with other key stakeholders to prepare system regulatory and risk assessments. Leads the creation of computer system procedures such as System Use, Change Control, Problem Reporting, Configuration Management, Performance Monitoring, Business Continuity, etc. Prepares and executes computer system validation strategies associated with Change Controls activities. Performs Periodic Reviews on regulated production computer systems. Supports validation unit in determining remediation strategies when automated and/or computer system require remediation. Demonstrates proficiency in applying Health Authority regulations as well as global and local guidelines, SOPs and procedures. Assists in establishing business requirements by studying and understanding assigned business procedures and processes. Participates in obtaining and understanding business and functional requirements and transforming them to clear, consistent, testable and measurable specifications. Leads the creation of business process flow diagrams, use case scenarios and system use documentation associated with business requirements. Logs and tracks variances that arise during validation testing. Prepares communication reports for project status updates (i.e., comparing actual vs. estimated milestones related to project scheduling and scope) Attends and participate in computer system validation project status meetings. * * *Regards, Kumar Reddy,* *Resource Specialist* * OSAIR Technologies LLC 301 N HARRISON STREET SUITE # 386 Princeton,NJ | 08540-3512 Voice : 630-206-9379* *Fax :732-289-6076 [EMAIL PROTECTED] *www.osairtech.com* *"We want to be your Trusted, Preferred & long Term Partner"* *Note: If you are not interested in receiving our e-mails then please reply to [EMAIL PROTECTED]<http://mail.osairtech.com/cgi-bin/compose.exe?id=01991591c8ba56cc62e720994fb077a65d18&new=&xsl=compose.xsl&[EMAIL PROTECTED]>with a "remove" in the subject line and mention all the e-mail addresses to be removed with any e-mail addresses, which might be diverting the e-mails to you. 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