Responsibilities
Preparation & implementation of SOPs related to the concerned department.
In-process checks during Manufacturing and packaging activities.
Online entries in BMR & BPR of products as well as verification & implementation of the same.
Handling of Quality Management System (Change Control system, Deviation, Incident & other related documents).
To prepare the Validation Master Plan, Site Master File, Drug Master File, Annual Product Quality Review, Plant Layout, and other documents related to QA.
To give line clearance before starting the batch in the manufacturing and packaging area.
Sampling of the bulk & finished products.
Monitoring and ensuring Positive Manufacturing Practice (GMP) at the manufacturing site.
To verify the dispensing of raw materials and packaging materials.
Responsible for ensuring that all necessary documentation is completed accurately, promptly, and in compliance with regulatory requirements.
Review the executed documents and review the documents for compliance including logbooks, BMR & BPR, Validation protocols and reports, etc.
To ensure proper document control on issued documents and master documents.
Control sample Management.
Any other responsibilities assigned by HOD.