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.
Work Authorization in US:
Rate on C2C:
Please ensure all candidates have all skills listed under "Required Skills"
in their resume.
Position: Validation Specialist
Address: Springfield, NJ
Length: 5+ months
Ideally has ArisGlobal (Health Registration) product experience.
4-8 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
Knowledge of GxPs, health authority regulations and computer validation
Candidate must have ability to multi-task, strong interpersonal and
communication skills, analytical skills and compliance interpretation
Performs effectively within a matrix/team environment.
Duties may include instructing, directing and checking the work of other
Requires working with members of different cultures in a global environment.
Strong working knowledge of computerized and automated systems used in a GxP
Execution of validation and compliance activities on computer system
validation (CSV) and equipment qualification projects according to health
Experience with computer system validation approaches 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 with minimal oversight.
Develops validation deliverables for computer related projects, including
but not limited to:
Regulatory Assessments, Risk Assessments, Requirements Specification,
Traceability Matrix, UAT Test Plan & Summary, Release Notices
Assists in the creation of system procedures such as System Use, Change
Control, Problem Reporting, Configuration Management, Performance Monitoring
Assists in preparing and executes production system validation strategies
associated with Change Controls activities.
Performs Periodic Reviews on regulated production computer systems.
Supports validation unit in executing CSV remediation strategies.
Executes validation activities in accordance with SP policies and procedures
within assigned project activities.
Assists in establishing business requirements by studying and understanding
assigned business procedures and processes.
Ensures the creation of clear, consistent, testable and measurable business
and functional requirements.
Supports the creation of business process flow diagrams, use case scenarios
and system use documentation associated with business requirements.
OSAIR Technologies LLC
301 N HARRISON STREET SUITE # 386
Princeton,NJ | 08540-3512
Voice : 630-206-9379*
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