Medical Writing,Clinical research, Quality control analyst
Resume:
* **** ** ********** ** 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:**************@*****.***
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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