Artwork Management
Preparation of CDA & QTA with Vendors
FDA Licence Activities with query draft
CAMS training software
QA SOP Preparation & Review
CFT SOP review with tracking,
SOP Harmonisation
Assist in Response to Regulatory queries received from customer
PR/PO activities
QMS tracking & Closure
Quality Management Review meeting Presentation Preparation
Monthly MRM Presentation preparation.
Master Documents handling (Management of Doc cell).
Other miscellaneous task.
Caliber handling
Vendor Management (Qualification & Requalification) a) For Raw Material & Packing materials.
b) VQ Documents review for Guideline Compliance
c) VQ Sample handling with evaluation
d) Vendor Physical site Audits
e) Compliance/CAPA Tracking