What are the responsibilities and job description for the CSV Lead position at AR Val services?
Job Description: -
· Experience in validating the Computerized System.
· Extensive validation experience in 21 CFR Part 11.
· Good understanding of GxP standards.
· Good Knowledge in Data Integrity
· Well acquainted with all the phases of Validation Life Cycle (VLC).
· Expertise in planning and execution of Validation Master Plan, requirements gathering (User Requirement Specifications), QRA.
· Extensive experience in creating, reviewing and executing test protocols (Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)), Traceability Matrix and Validation Summary Report (VSR).
· Expertise in technical writing and reviewing of Standard Operating Procedures (SOPs), Work Instructions.
· Excellent knowledge and good working experience in executing Gap Analysis, and Change Control Process.
· Extensive experience in performing Risk Assessment.
· Good communication skills and English fluency.
Experience in validating few of this below equipment:
· Particle Measurement System
· FT-IR Spectrophotometer
· Gas Chromatography
· Liquid Chromatography
· Carbon Dioxide Headspace Analyzer
· Differential Scanning Calorimeter
· Metrohm
· UV-Vis Spectrophotometer
· Malvern Mastersizer
· Mass Spectrometer
· TruScan RM Analyzer
· MTS System
· Instron
· ICP-OES Spectrometer
· Mitutoyo Co-ordinate Measurement System
· TOC- Total Organic Carbon
· Sensitech TempTale Manager
· Ellab Data Logger Perform sys
Job Types: Contract, Full-time
Pay: $52.00 per hour
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Ability to commute/relocate:
- Bloomington, IN 47403: Reliably commute or planning to relocate before starting work (Required)
Work Location: One location
Salary : $52 - $0