Key Responsibilities:

* Responsible for review of URS, DQ and vendor/ supplier’s documents related to
qualification.
* Responsible for preparation and review of Validation/ Qualification protocol
and report.
* Responsible for execution and review of Qualification / Re-Qualification and
Validation activity of Equipment / System / Facility and Plant utilities.
* Responsible to co-ordinate with manufacturing, Engineering and QC personnel
for respective Qualification / Validation / Re-qualification activity for
timely completion of activities.
* Responsible for preparation and review of media fill and hold time protocol
and report.
* Responsible for preparation of Standard Operating Procedures of Quality
Assurance Department.
* Responsible for assessment of Change Control, Deviation, CAPA, Investigation
etc.
* Responsible to prepare protocols of process validation and cleaning
verification/validation.




* Responsible to conduct sampling activity as per the protocols (Process
validation and clearing validation etc.).
* Responsible for preparation, review and execution of risk assessment activity
related to equipment/ process/ facility/ system.
* Responsible for preparation and updation of Annual Validation Planner.
* Responsible for review of the master and executed documents of cross
functional team (CFT).
* Responsible for review of master batch documents.
* Responsible to review the different type planner and calibration
certificates.
* Responsible to monitor cGMP compliance at shop floor.
* Activities other than defined in the Job responsibility are to be done, as
per the requirement of HOD, by following HOD’s instruction and guidance.

📌 Executive, QA Validation (Ahmedabad)
🏢 Amneal India
📍 Ahmedabad