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