Description:
- Preparation of CDA & QTA with Vendors
- FDA Licence Activities with query draft
- QA SOP Preparation & Review
- CFT SOP review with tracking,
- Assist in Response to Regulatory queries received from customer
- Quality Management Review meeting Presentation Preparation
- Monthly MRM Presentation preparation.
- Master Documents handling (Management of Doc cell).
- Other miscellaneous task.
- 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
