KRUPA PATEL

****, **** ****, ******, *** Jersey, 08817

Contact Details:

E-mail: ac8jkz@r.postjobfree.com

Phone Number: +1-732-***-****

PROFESSIONAL EXPERIENCE

Schwitz Biotech - Ahmedabad, India

(A WHO GMP company & ISO 9001 – 2000 company/ International Quality Excellence Award Winner Company) Executive - Regulatory Affairs and QA December 2016-September 2018

Preparation of Dossiers (eCTD Dossier) and meeting with the requirements of the Ministry of Health of several countries like Nigeria, Mozambique, Sierra Leone, Bangladesh, CIS countries, Cambodia, Sri Lanka, Lebanon, and many more.

In-depth knowledge of referring to USP, BP, EP for preparation of Dossiers and for reviewing test methods for preparation of certificate of analysis for Finished products for Exports.

Compilation of materials for license renewals, updates and registrations.

Review labeling and labels for compliance with regulatory requirements.

Review changes to existing products and SOPs to define the requirements for regulatory submissions.

Practical Experience of documentation in the QA Department regarding application with the FDA. Gitar Laboratories - Ahmedabad, India

Quality Assurance Associate July 2016-November 2016

Oversaw 5 to 10 test result reports of drug sample describing whether it met the criteria or not and checking impurities of Drug samples and Related substances like residual solvents using HPLC or GC method.

Identification of Drug by Infrared Spectroscopy (IR), Nuclear magnetic resonance Spectroscopy(NMR) Troikaa Pharmaceuticals Ltd - Ahmedabad, India

Quality control, Quality Assurance and Production Intern May 2015-July 2015

Overlooked development and manufacturing of drugs, checking various parameters in Quality Assurance and Quality Control, Have operated Tablet making equipment, capsule filling machine

Performed Sterility testing, Bacteria endotoxin testing, formulations and development, filling and Packaging EDUCATION

Post-Graduate Diploma in Healthcare and Hospital Management (6 months Part-Time) Ahmedabad Management Association - Ahmedabad, Gujarat, India August 2017 Project - Highway tollbooth preparedness for medical emergencies- A study of tollbooths around Ahmedabad Bachelor of Pharmacy (Aug 2012 - June 2016)

Nirma University - Ahmedabad, Gujarat, India June 2016 Cumulative Performance Index (CPI): 7.21/10 (GPA = 3.6/4) Courses - Knowledge on European Medicines Evaluation Agency, Organization for Economic Co-operation and Development, Code of Pharmaceutical Ethics, Drugs and Cosmetics Act, Narcotic Drugs and Psychotropic Act.

Thesis and Poster Presentation: “Diabetic Retinopathy: A Comprehensive Review” and created advertisement brochure on drug “Minoxidil”- the first topical brand (ROGAINE) approved by FDA as a part of academic curriculum.

CERTIFICATIONS & SKILLS

Certified as “Registered Pharmacist” by Gujarat state of Pharmacy council in the year 2018

Certificate of Appreciation received from Schwitz Biotech and Recognition of “Excellence in Quality Management” Given in the city of Miami, Florida on July 26 of the year two thousand and eighteen (The Bizz Awards 2018 held at Miami Florida, USA)

Regulatory skills- Preparation of eCTD Dossiers and meeting with the statutory requirements of Ministry of Health of several countries, Documentation, Reviewing to the Pharmacopoeias, Application and renewal of License, Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners, participate in evaluation of regulatory compliance of document / product / process /test methods changes, Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required.

Technical skills - Proficient in Microsoft Office (Power-point, Excel and Word) Wordpress, Chemdraw, basic knowledge of Corel Draw X7 for preparation of Artwork for Pharmaceutical packing material

Soft skills - Strong communication, excellent teamwork, self-management, time management, analytical, flexibility, extremely organized, multitasking, self-motivated, conflict resolution, report validation, documentation writing

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