Quality Assurance Medical Device

SNEH PINGLE

** ******** ****** *** #**, BOSTON, MASSACHUSETTS 02115

857-***-**** (C) ****.******@*****.***

SUMMARY

I am a Dedicated, Enthusiastic, Self-Motivated and Multilingual Regulatory Affairs Professional with one year of

combined experience in Production, Quality Assurance and Molecular Techniques who posses MS in Regulatory

Affairs for Drugs, Biologics and Medical Devices along with Master of Technology and Bachelor of Engineering

in Biotechnology. Experience in writing New Drug Development Plan, SOPs, Pre-IND Meeting Request, Notice

of Intent to request SPA for Carcinogenicity, Informed Consent, Response to FDA Warning Letter, Regulatory

Strategy for 510 (k) and PMA, Case Briefing etc,. Managed team of 10 operators to execute extraction of product

and calibration of equipments and received constant positive feedback from managers and colleagues. Posses

strong written and verbal communication skills, ability to meet deadlines and partner across different departments

to meet the needs of company.

EXPERIENCE

Northeastern University April 2011 – April 2013

Graduate Student

• Knowledge of regulatory requirement for US, Europe, Canada, Singapore, Australia, India, China and

Latin America.

• Knowledge and experience of ISO 13485, ISO 14971, ISO 10993-1, ICH, cGMP, QSR and Good

Documentation Practices.

• Working knowledge of eCTD software (Aspire eCTD).

• Experience of compiling regulatory submissions like IND, NDA, ANDA, BLA, IDE, 510 (k), and PMA

for USFDA.

• Experience in conducting Feasibility Design Control, Evaluation Design Control and Final Design

Control for an electrophysiology (EP) ablation catheter and developed regulatory strategies for US,

Europe, Canada and Japan.

Concord Biotech Limited, Dolka, Gujarat, India July 2009 – October 2009

Production Engineer (Trainee)

• Performed downstream recovery of the TECROLIMUS (an Immunosuppressant) by using techniques

such as filtration, aqueous two phase extraction, carbon treatment, crystallization and vaporization and

managed team of 10 operators.

• Inferred and implemented relevant guidelines for preparation of standard operating procedures in

plant.

• Completed and reviewed batch process records.

• Reviewed and generated cGMP documents such as CAPA, Deviation (Non-conformity) and

change control.

• Reviewed validation/verification protocol and report.

• Assisted in training management system for individuals by maintaining training records.

• Performed in process Quality Assurance activities.

• Performed calibration of reactors and other equipments involved in the recovery process.

• Responsible for packaging and dispatching the final product to warehouse.

INTERSHIP

Plethico Pharmaceutical Limited June 2008- August 2008

• Assisted in Batch Processing Record review in Quality Assurance department.

• Performed in process Quality testing for tablets such as friability test, disintegration test, dissolution test,

weight uniformity and tablet thickness and hardness tests.

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• Review of package label.

• Assisted in production for oral dosage form.

Bhopal Memorial Hospital and Research Centre June 2006 – July 2006

• Gained hand-on experience in molecular techniques such as karyo-typing, gel-electrophoresis,

chromosome mapping, hybridization etc.

• Worked on Fluorescence activated Cell Sorter to separate and study different type of cells in the

suspension.

EDUCATION

Northeastern University, Boston MA April 2011– April 2013

M S in Regulatory Affairs for Drugs, Biologics and Medical Devices

GPA: 3.642 out of 4

SRM University, Tamil Nadu, India August 2007- June 2009

Master of Technology in Biotechnology

GPA: 8.288 out of 10

Shri Rawatpura Sarkar Institute of Technology and Sciences, MP, India July 2003- June 2007

Bachelor of Engineering in Biotechnology

Percentage: 73.9 out of 100

CONTINUING EDUCATION

Certifications of FDA CDER learn and CDRH learn for: CDER and CDRH learn is an online tutorial which

consists of training modules covering premarket and post market issues.

• Compliance: Office of Compliance Overview, Manufacturing and Product Quality, Scientific

Investigations, Bioequivalence and Good Laboratory Practice Inspection Programs, Enforcement

Responsibilities, Risk Management and Drug Surveillance

• New Drugs: Role of Office of New Drugs, The Drug Review Process, Biologics Review, Pediatric

Regulations

• Generic Drugs: Generic Drugs Overview, Abbreviated New Drug Review Process.

• Premarket Notification Process- 510(k) and 513(g), Bioresearch Monitoring (BIMO), Device

Establishment Registration and Listing, Quality System Regulation 21 CFR Part 820, Medical Device

Reporting.

PRESENTAIONS

• Participated in poster presentation in International Workshop on Recent Advances in Bioengineering held

on February 7-9, 2008 organized by School of Bioengineering, SRM University.

• Participated in City Fair of Intel Science Talent Discovery Fair 2002.

PROFESSIONAL MEMBERSHIP

Regulatory Affairs Professional Society (RAPS)

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