VTekis Consulting LLC provides complete solutions for Staff Agumentation, Recruitment Process Outsourcing, Contract Hiring, Direct Hire and Outsourced Solutions. Our goal is to deliver quality professional services to our clients not just to find someone to do a job, we match the right professional for your staffing needs and earning confidence through the proper assignment of people. This alignment of people and companies allows us to create opportunity. Most importantly, We don’t consider the process complete until we find the perfect fit.
Description:
Experience in validating the Manufacturing Equipment.
Extensive validation experience in 21 CFR Part 11, Part 820.
Good understanding of GxP standards.
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).
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.
Experience in validating few of this below equipment:
Thanks and Regards,
Mohammed Ilyas,
PH - 229-264-4029 Text - 770-852-8474.
All your information will be kept confidential according to EEO guidelines.