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