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 Lead
Address: Springfield, NJ
Length: 9+ months
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
Knowledge of GxPs, health authority regulations and computer validation
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
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
Good project management skills.
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
Works independently and within a team, under the guidance of the Validation
Unit, on CSV projects and provides guidance on validation concepts with
Develops validation deliverables for computer system related projects,
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
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
OSAIR Technologies LLC
301 N HARRISON STREET SUITE # 386
Princeton,NJ | 08540-3512
Voice : 630-206-9379*
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