* **** ** ********** ** Medical writer in Springer Nature previously known as Crest at Pune, Maharashtra, India from June 2014 to June 2015.

2+ Years of experience as Executive Quality Controller in Piramal Healthcare manufacturing facility at Pithampur, MP, India from June 2005 to August 2007. Piramal Healthcare is India’s leading pharmaceutical company and one of the leading custom medicines manufacturing company in world with turn over of over 1 billion rupees.

1 years experience in Customer service and retail marketing in Macy’s USA from Jun’08 to May’09. Macy’s is one of the oldest and biggest high end luxury chain of stores in USA.

Post Graduate Diploma in Patent Law

Nalsar University of Law, Hyderabad

2011

Diploma in Clinical Research

Catalyst Clinical Services, New Delhi

2010

Post Graduate Diploma in Regulatory Affairs

Jamia Hamdard University, New Delhi

2010

Bachelor of Pharmacy

S.G.S.I.T.S., Indore

2005

Clinical research

Medical writing, Clinical Research Organization, Regulatory Affairs, Pharmacovigilance

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Clinical Research and Regulatory Affairs Knowledge

1.Knowledge of Clinical Trial and phases of Clinical Trial.

2.Knowledge of Clinical Trial Terminologies.

3.Knowledge of all essential Clinical trial Documents.

4.Knowledge of Regulatory affairs and its importance.

5.Knowledge of different countries regulatory bodies and their guidelines like USFDA, TGA, MHRA, EMEA etc.

6.Knowledge of IND, NDA, ANDA and BLA

7.Knowledge of Drug Development Process and Regulatory Role.

8.Knowledge of Bioavailability and Bioequivalence study.

9.Knowledge of Pharmacovigilance and its importance

10.Familiar to Periodic Safety Update Reports (PSURs)

11.Knowledge to ICH and FDA Guidelines

12.Well Familiar of GCP, CGMP, GLP

13.Familiar to CFR, CTD

Instrument Operation

Knowledge of all the instruments used in testing of Finished Goods

(Tablets, Capsules, Injections and Eye drops)

1.High Performance Liquid Chromatographer

2.IR (Infrared Spectroscopy)

3.Dissolution tester

4.Hardness tester

5.UV / Vis spectrophotometer

6.Dial Caliper

7.Viscometer

Drug Testing

1.Testing of different drugs like multivitamin tablet, Saridon tablet, Gentamycin injection, Paraxin capsule, Creon capsules etc.

2. Calculation and documentation of the result.

Documentations And Records Maintenance

1.Documentation of procedures & test results following CGMP/WHO guidelines

2.Protocol filling & SAP entry in system

3.Maintained and review records such as Shower maintenance records, Glassware cleaning records, Temperature & Humidity records, Washing machine cleaning records, etc.

Organization

Springer Nature, Pune, India.

Springer Nature works in many professional areas such as Medicine, Transport, Legislation and Engineering and Management. In the medical sector, they provide doctors of all specializations as well as healthcare professionals, pharmacists and further experts, with high-quality content and updates about novelties and developments.

Period

June’14 to May’15

Position

Medical Writer

Responsibilities

1.Worked for Springer nature database called Adis Insight

2.Created and updated clinical trial profiles using information from different clinical trial registries, Sacc files, company media releases, companies drug pipeline and articles published from journals.

3.Detailed review of each trial with key information such as status, phase, design, location, patient segments, endpoints, subject characteristics, treatments, results, adverse events and a timeline of key trial events.

Organization

Piramal Group

Nicholas Piramal India ltd (NPIL) has manufacturing plant at many location including Baddi, Mumbai, Amarnath, Pithampur, Deonar, UK, USA etc. The formulation plant at Pithampur is a modern plant conforming CGMP requirements. The company has facility for manufacturing following dosage forms

1.Tablets – Plain, sugar coated, film coated

2.Hard gelatin capsules

3.Ophthalmic drops (FFS Technology)

4.Injectibles – Ampoules and Vials

The plant has been accredited from WHO GMP certificate and ISO 9001.The plant has production department, Quality control department and validation department.

The quality control department has raw material testing, finished goods testing, packaging material testing and Micro labs.

Period

July’2005 to Aug’2007

Position

Executive Quality Controller

Responsibilities

1.Handling of different Drugs and Dosage forms like Tablet, capsules, injection etc.

2.Handling of different Instrument used for testing like Hardness tester, viscometer, pH meter, Dial caliper, Dissolution tester, IR (Infrared spectroscopy), UV, various balances etc

3.Testing of different drugs Like Multivitamin tablet, Saridon tablet, Gentamycin injection, Paraxin capsule, Creon capsules etc.

4.Documentation of procedures & test results following cGMP/WHO guidelines

5.Daily Review of records like Instrument usage record, Primary and secondary standard usage record, Calibration record, Shower records, Washing machine records, Humidity and Temperature control records.

6.Protocol filling & SAP entry in system.

7.Review and update of SOP

Organization

Macy’s Corporation, Pittsburgh, US

Period

June’08 to May’09

Position

Customer Service Representative

Responsibilities

1Attending customers calls.

2Customer management

3Billing

Nationality

Indian

Marital Status

Married

Date of Birth

27-Oct-1981

Sex

Female

Languages

English, Hindi and Marathi

Visa status

EAD

Name and Contact Details

Company and Role

Poornima Malagi

Ph# +1-996-***-****

Email:add7et@r.postjobfree.com

Banglore, India

Senior Process and Quality Analyst

Springer Nature

SN Technology & Publishing Solutions

Upper Ground Floor

Wing B, Tower 8,

Magarpatta City SEZ, Hadapsar

Maharashtra, Pune 411 013,

INDIA, Ph# +91-20-710*****

Year – 2014-15

Nidhi Jaglan

Ph# +1-973-***-****

Texas, USA

Executive Quality Controller

Piramal Healthcare

Piramal Enterprises Limited

Plot 67-70, sector II

Pithampur, Indore

Madhya Pradesh 454775

Year – 2005-2007

I hereby certify that all the information furnished above is correct to the best of my knowledge.

Deepmala Jaiswal

Experience Summary

Professional Education

Area of Professional Interest

Professional Skill Sets

Professional Experience

Personal Details

Reference

Declaration

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