Job Description :
Job Description:

1. Experience in validating the Laboratory Equipment, Computerized System and Manufacturing Equipment.
2. Should have system verification knowledge.
3. Extensive validation experience in 21 CFR Part 11.
4. Good understanding of GxP standards.
5. Well acquainted with all the phases of Validation Life Cycle (VLC
6. Expertise in planning and execution of Validation Master Plan, requirements gathering (User Requirement Specifications
7. 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
8. Expertise in technical writing and reviewing of Standard Operating Procedures (SOPs), Work Instructions.
9. Excellent knowledge and good working experience in executing Gap Analysis, and Change Control Process.
10. Extensive experience in performing Risk Assessment and Failure Modes and Effects Analysis (FMEA
11. Good communication skills.


Required Skills:

1) Good Experience in validating the Laboratory Equipment, Computerized System and Manufacturing Equipment.
2) Should have good system verification knowledge.
3) 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
4) Extensive experience in performing Risk Assessment and Failure Modes and Effects Analysis (FMEA
5) Excellent knowledge and good working experience in executing Gap Analysis, and Change Control Process.