Rameshvari Tendulkar Dhandar Email & Phone Number

FDF3, Indore

1. To manage the SOP flow activities in Documentum as a Site SOP coordinator.2. To verify the training certificate and manage the User accounts in Documentum. 3. Review, Issuance, retrieval and destruction of Specification and Standard Test Procedures of Raw Material, Packaging Material, In-process Materials and Finished Product.4. To prepare, update.

Indore, Madhya Pradesh, India

Pithampur

1.Preparation, review and Updation of the QA related SOPs for compliance of quality system.2.Review of Master Documents3.Review of Vendor qualification documents 4.Preparation and review of the Annual product quality review5.Change Control Management6.Internal Audit7.Management of Control sample Area.8. SAP9. Validation.10. Quality Management System

Pithampur

1.Preparation, review and Updation of the QA related SOPs for compliance of quality system.2.Review of Executed Batch Production Records.3.Verification and compliance of documents for Regulatory submissions as per ANDA checklist.4.Verification of Analytical Documents for Regulatory submission.5.Co-ordination with Regulatory for response to deficiency /.

Goa

1.Reviewing of CMC documents for ANDA & EU filing of oral drug products and semi solid products.2.Review and approval of documents of NCE molecules for IND filing.3.Good exposure to Quality systems, formulation technology and International regulatory requirements for pharmaceuticals as worked in the Audit & Regulatory compliance and manufacturing.

Handled bulk packing efficientlyManpower handlingSOP preparationDaily documentation.Reviewing of Batch cards.In process quality control checks such as disintegration test, hardness test, friability test, Leak test of strips and blisters.Weekly output report.Assisting in monthly production planning.

B.Pharm.Sc

Activities and Societies: Elected as Magazine Secretary for the College Magazine Pharm Echoes 2004. Done a first aid course of St. John.

Education record