Quality Control Medical Device

** ********** ******, ********* ***, Waltham, MA.*2451

219-***-**** ****.*****@*****.***

ADITYA PATIL

Highlights:

• Master in Regulatory Affairs for Drugs, Biologics and Medical devices.

• 2+ year progressive experience in Quality control of tablet in pharmaceutical industry.

• Knowledge of FDA.

• Handle hardness tester, friability tester, and Dissolution and Disintegration equipments.

• Excellent problem solving, team building, Judgment and decision making skills.

• Good ability to solve problems in given time.

• Excellent Documentation and communication skills.

• Proficient in Microsoft office, word, Excel, PowerPoint.

Education:

• Northeastern University, Boston, MA.

MS in Regulatory affairs for Drugs, Biologics and Medical Devices. (January 2014).

Courses:

Introduction to Drug and Medical Device Regulations, New Drug Development: Regulatory

overview (IND, eCTD, NDA, ANDA, GLP, GCP, GMP), Biomedical Product development,

Biologic Development: Regulatory overview, Medical device development: Regulatory

overview (MDR, MDVR, 510K, PMA, UDI, CAPA, FDA, ISO), Biomed Product

Development.

• North Maharashtra University, Jalgoan, Maharashtra, India.

Bachelor in Pharmacy. (June 2008).

Courses:

Pharmaceutics (formulation of all dosage forms, evaluation of solid, liquid and semisolid

dosage forms, Quality control test of all dosage forms), Pharmaceutical Analysis

(Chromatography, HPLC, GC, FTIR, Qualitative analysis, validation of analytical

instruments), Medicinal Chemistry (Synthesis of different compounds, evaluating percentage

purity, Organic chemistry, Pharmacology(with lab).

Involved in the Research Practical Performing extraction (continuous hot water extraction

using Soxhlet apparatus), Separation (column chromatography, Paper chromatography) and Chemical

identification tests.

Experience:

IPCA Laboratories, Silvassa, Dadra and Nagar Haveli, India.

Quality Control Officer: (July 2009 – September 2011).

• Conduct Quality Analysis of raw material, in-process and finished product.

• Monitor testing procedure to ensure that all tests are performed according to GMP

specifications, standard test method or protocol.

• Implement guidelines and system to ensure quality standard.

• Investigate and report questionable test results.

• Maintaining batch record, product development record and sampling and testing protocol.

• Routinely interacted with the R&D, validation, manufacturing and regulatory departments to

exchange supporting information.

• Prepare for internal audits; document all the records as per FDA guidelines.

• Supply quality control data necessary for regulatory submission.

• Facilitated world best regulatory agencies such as US-FDA, UK-MHRA, Europe-EDQM,

WHO evaluations and communicated audit findings and implementing corrective actions.

• Performs the coordination and preparation of document packages for regulatory submissions

from the Quality Department.

• Reviewed Drug Master Files (DMF) and Annual Product Quality Reports (APQR).

• Assisted the Drug Regulatory Affairs Department in the preparation of FDA required annual

reports for Abbreviated New Drug Application (ANDAs).

• Assisted in the preparation of SOP’s.

K. D. Gavit, College of Pharmacy, Nandurbar, Maharashtra, India.

Professor: (July 2008 – June 2009).

• Explain and perform practical on different dosage forms, Quality control of different dosage

form.

• Participated in All India Council of Technical Education (AICTE) sponsored program on

“Hurdles and challenges in Quality Control and standardization of Herbal Pharmaceuticals”.

• Participated in All India Council of Technical Education (AICTE) sponsored 2 day national

seminar on “Current challenges and novel approaches in pharmacological research”.

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