SHWETA CHUGH GHAI

Address

H.No 393 , Sec 37Faridabad Haryana.

Ph.: +91-9810568007.E mail: shwetachugh1104@yahoo.co.in

Objective: Seeking a position that offers professional growth while being resourceful, innovative and flexible and to utilize all the skills and abilities that I have augmented and to garner appreciation and make the organization I work for proud of me.

Area of Interest:

Regulatory Affairs and Compliance.

Total Experience: 8 years 11 months

Currently employed with:

Kinapse India: Providing Life Sciences Consulting and Outsourcing services to the global life sciences industries. http://www.kinapse.co.uk/

Working as Senior Regulatory Associate –CMC Strategic Author.

Job Profile: Actively lead regulatory evaluation and assume responsibility for own function strategic

project work.

Proactively communicate CMC regulatory strategy, key issues and other critical topics throughout the lifecycle to Client Team Leader/Strategic Team Leader (and Program Leader, if warranted) to meet contractual agreement.

Prepare and author all variants of CMC Quality submission components in line with functional team expectations (e.g. QoS, Module 3, Agency Queries, etc.) under minimal supervision.

Prepare post approval changes for legal entity name changes for EU and MoW mar-kets.

Collaborate with Client and or Strategic Team Leader to ensure that strategic priorities for the projects are understood and implemented.

Implement and drive CMC submission activities (planning, review, co-ordination and sub-mission) for assigned projects/products

Prepare quality updates and manage the CMC lifecycle of projects.

All quality documents to be prepared using Client GCMC templates, using regulatory in-telligence provided by technical teams/databases, maintained appropriately within Client’s systems e.g. Global Documentation Management System (GDMS), PDM.

Maintain all Kinapse and Client quality and tracking systems.

Past Experiences:

Previously worked with Panacea Biotec.Ltd, New Delhi in Regulatory Affairs as Executive Regulatory affairs.

Previously worked with PanEra biotec (an association of Panacea Biotec at lalru, Chandigarh, India) as Scientific officer in Production of vaccines

Job Profile @ Panacea

Prepare dossiers for Domestic market as per CTD Format (CDSCO) guidelines (H1N1,Anthrax ,Pentavalent ,hexavalent , polio vaccine etc)

Preparing dossiers for Rest of the World countries in compliance with ICH-CTD, ACTD, for emerging markets as per country specific guidelines, to refer USFDA and EU as well.

Responding to the queries received from NRA or other concerned regulatory bodies (country specific).

Ensuring that a company’s product comply with the regulations of the regulatory requirement of different countries.

Keeping up to date with company’s product range.

Responsible for reviewing documents of Drug substance and Drug product eg. Sop’s, Batch records, Package inserts, Summary of product characteristics and Patient Information Leaflet.

Reporting SAE’s to the concerned regulatory authorities within the time frame.

Review of technical documents like Finished Product Specifications, Raw Material Specifications, Certificate of Analysis and Stability Studies etc.

To assist the external auditors while their visit to the manufacturing plant and provide them with the required supporting documents during audit.

Skills developed at PanEra Biotec Pvt. Ltd. (Production and QA) Hands on experience of working in cGMP conditions and a facility approved by WHO Achieving the set production target well on time. Purification of antigens by Downstream Processing (aP, Diphtheria, wP) Upstream processing of Recombinant Hepatitis B surface antigen Validation and revalidation of process and equipments. Training and retraining of personnel in production. Co-ordinating intradepartmental activities Implementing a healthy channel mix with other departments. Ensure the Environmental monitoring of production area as per GMP requirements. Conducted internal audits of QA, QC, warehouse etc.

Scholastic Background: Completed MBA in Operations Management from Symbiosis, Pune (distance

learning) M.Sc (Biotechnology); 2007, CGPA 8.2 from Amity University, Noida, U.P. B.Sc (Biotechnology);2005, 76% from Mody Institute of Education & research, Jaipur

Project Work in M. Sc

Completed 6 months dissertation from All India Institute of Medical sciences, New

Delhi (in ocular biochemistry)

Proficiencies:

Platforms : WINDOWS Application : MS Office

Personal details:

Name : Shweta Chugh GhaiHusbands Name : Mr. Ashish Ghai Date of Birth : 26th June 1984Sex FemaleMarital Status MarriedLanguages Known English, Hindi & French

References:

Shall be provided on request

Declaration:

I hereby declare that the above information is true to the best of my knowledge.

Date: Place: New Delhi

(Shweta Ghai)