Medical Device Quality Control

SWETHA KALIDINDI

** ******** **, ******, ** *****

Email: ******.***@*****.*** Tel: 1-732-***-****

JOB TITLE: Regulatory Affairs Associate

JOB OBJECTIVE: Hands-on position in Regulatory Affairs, either in a Pharmaceutical or

Biotech company.

ACADEMIC CREDENTIALS:

Master’s Degree in Regulatory Affairs at Northeastern University, Boston MA, graduating in

March 2010 with current GPA of 3.7

Bachelor’s Degree in Pharmacy from Osmania University, Hyderabad, India 2009 with a GPA of

3.6

REGULATORY SKILLS:

Strong working knowledge of the regulatory processes for Pre-marketing Approvals, (PMA’s),

Investigational New Drugs (IND’s), Abbreviated New Drug Applications (ANDA), Corrective

and Preventive Actions (CAPA’s), Medical device Reporting (MDR), eCTD’s.

EXPERIENCE:

Globepharma, New Brunswick, NJ

Assistant Quality Control Technician: Jun 2009 – June 2010

Plan, initiate, implement and oversee department activities with focus upon ensuring

attainment of department objective.

Investigate, develop and implement new creative ways to accomplish department goals in

most cost effective and productive manner while maintaining high quality standards.

Implementing IQ, OQ and PQ procedures and protocols for validating pharmaceutical

sampling devices and equipment.

Review all testing data for accuracy and compliance to company procedures of Sampling

Devices like Liquid Samplers, Powder Samplers and other Pharmaceutical Lab

Equipment.

Update Standard Operating Procedures.

SMS Pharmaceuticals Pvt. Ltd, Hyderabad, India

Internship: May 2006 – Dec 2006

Trained in Manufacturing of Bulk Drugs, Development of Bulk Active Pharmaceutical

Ingredients and Intermediates.

Gained thorough Knowledge of HPLC and other test methods as well as instrumentation.

Trained in operating incineration systems for gaseous waste, liquid wastes as well as

Solid wastes.

Trained on how the equipment meets WHO GMP Standards.

ACADEMIC ACHIEVMENTS:

Participated and received certificate in Indian Pharmaceutical Association – AP State

Branch, Hyderabad, India for free Medical service.

Won Silver medal as a runner up at the Mumbai Intel National Science Fair for research

work titled Bio Acidic Indicator in Jan 2002.

COMPUTER SKILLS:

All Microsoft Office Applications: Very High Proficiency

Hardware and Programming Languages: C, C++ and SQL

Fluent in English, Hindi, and Telugu Languages

RESIDENTIAL STATUS:

Permanent Resident

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