computer system validation in any where in india

posted
contact
randstad india
position type
permanent
apply now

posted
location
any where in india
function
Information Technology
position type
permanent
experience
6-9
reference number
60636
contact
randstad india

job description

computer system validation in any where in india

Primary Skill :-

 

Pharmacy Back ground

6 years of Computer System Validation experience in a GxP-regulated environment, with

exhibited knowledge and proficiency of system validation and quality activities.

·Experience working in a GXP regulated environment

·Experience working in Quality Management Systems

·Support all aspects of Computer System Validation and global IT activities for the systems that

support GxP processes.

·Should have good knowledge of regulations – 21 CFR, GAMP5, Annex 11, GxP, OECD

guidelines, etc.

·Knowledge of GxP Analysis, Gap Assessment.

·Understand clients CSV, Quality and Risk management strategy, define and align with the

processes and procedures for the program/project

·Assist in providing strategic inputs for CSV projects

·Able to prepare CSV life cycle documents /qualification related protocols (like VP, VR, URS, FRS,

FRA, DS/CS, IQ, OQ, PQ, RTM)

·Excellent Communication, Interpersonal and Presentation skills

 

skills

computer system validation

qualification

B.Sc, B-Pharma, M-Pharma