Key Responsibilities
To prepare and review of URS, DQ, QRM, FAT, SAT, and vendor/ supplier’s
documents related to qualification.
To execute Qualification / Re-Qualification and Validation activities of
Equipment / System / Facility and Plant utilities (HVAC system, Autoclave,
Isolator, Filling machine, Washing machine, Depyrogenation tunnel, UAFs,
Packaging equipment, Water system, Pure steam generation and distribution
system, Nitrogen/compressed air distribution system etc.).
To perform qualification activities like air flow visualization study,
Temperature mapping of Rooms/Chambers, Packaging validation, Transport
validation etc.
To co-ordinate with manufacturing, Engineering, Material Management, QC
personnel and other users for respective Qualification / Validation /
Re-qualification activities for timely completion of activities.
To prepare and review Validation/ Qualification protocols and reports (IOQ,
PQ, RQ, CQ, other miscellaneous qualification documents etc).
To prepare and review process validation, cleaning validation, media fill and




hold time study protocols and reports.
To prepare and review of SOPs of Validation and Quality Assurance Department.
To prepare and update Annual Validation Planner.
To prepare and execute project validation master plan for commissioning and
qualification of recent/modified facility.
To assess Change Control, Deviation, CAPA etc. and participate in
investigation triggered through deviation, OOS, OOT or other failures.
To involved in QMS related activities i.e initiation and review of QMS
elements.
To prepare, review and execute risk assessment activity related to equipment/
process/ facility/ system.
To conduct sampling activities as per the protocols (Hold time, Process
validation and cleaning validation etc.).
Establish, monitor and maintain Validation function for audit readiness.
To prepare VMP and SMF.
To implement contamination control strategy at site.
Complete Validat

📌 Senior Executive, Qa Validation Ahmedabad
🏢 Amneal
📍 Ahmedabad