Job Description
QMS Documentation
CAPA
Deviation
Change Control
Handling of Deviations related to procedure and equipment functioning through detailed
investigation tools.
Handling of CAPA based on investigation and proactive actions.
Preparation and Review of Quality Risk Assessment/ Impact Assessment related to
engineering and cross functional teams.
Subject Matter Expert (SME) for Engineering QMS during compliance to the Regulatory,
Customer and EHS Audit observations, related to Engineering Department.
Preparation and review of engineering relevant Operation, Maintenance, Cleaning SOP’s.
Preparation and execution of Protocol and Reports for Validation of Water System and
other Major Equipment’s.
Preparation and execution of non-routine study protocol and retrospective review for
equipment and its functioning.