Ensure cGMP compliance.
Responsible for HVAC Qualification and re-qualification activities at site.
Responsible for monitoring, tracking of qualification and validation planner and compliance.
Responsible for Equipment qualification, validation & re-qualification activities at site.
Responsible for preparation of VMP and to update as per requirement.
Responsible for handling water system qualification & re-qualification activities.
Responsible for compressed air system qualification & re-qualification activities.
Responsible for Preparation and Review of Process Validation/Verification Protocol, Hold Time Study Protocol, Cleaning Validation/Verification Protocol and Process Validation/Verification Report, Hold Time Study Report, Cleaning Validation/ Verification Report to monitoring and sampling of validation batches.




To collect the Process Validation Sample/Hold Time/Packing Validation Sample as per sampling plans from different stages and different location of process.
Responsibilities for facility Qualification.
To coordinate and execute validation activities & to ensure compliance.
To ensure & co-ordinate for execution of temperature mapping activities at site & its compliance.
Review & verification of environmental monitoring condition through BMS system.
Responsible for review, verification & certification of external documents such as certificates, manuals, SOPs.
Responsible to report near miss/unsafe condition with respect to safety.
Responsible to attend Safety trainings and to participate in different EHS events.
Adherence to Data Integrity Policy.

📌 Executive / Senior Executive Qualification Baddi
🏢 Acme Generics
📍 Baddi