Senior QA Analyst

Bachelors degree in engineering / science.
3+ years of experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5. Experience with the implementation of Quality Management systems (Track wise/ Master control / ETQ/ CEBOS) Should be able to Develop validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments. Should be able to create project Deliverables which will encompass validation plans, specifications, test protocols and standard operation procedures Good communication and technical writing skills are a must. Should be able to work Independently. Should be Flexible to handle multiple projects parallelly. Should have experience in Managing clients and Stakeholder. Strong Manufacturing or Business process knowledge will be added advantage. Any Automation skill set /ability is added advantage