- 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 Valuable 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.