Medical Device Quality Control

ABHILASHA SHARMA

*********.******@*****.*** • *** Mass Ave #72 Boston MA 02115 • Phone Number: 857-***-****

EDUCATION

Northeastern University, Boston, MA Jun 2015 Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices

Relevant Coursework:

New Drug development, Medical Device development, Canadian/Australian Medical device regulations, Validation of clinical trials, Global Biotechnology, FDA law, Human Experimentation, Advertising and Promotion of Drug

Gujarat University, Gujarat, India Apr 2011 Bachelor Degree in Pharmacy

Relevant coursework:

Pharmacology, Toxicology, Pharmaceutical Analysis, Clinical Pharmacy, Pharmaceutical Jurisprudence

PROJECTS AND SKILLS

Prepared mock IND, IDE, Informed Consent, NDA, BLA, 510(k) submissions by researching, summarizing, and reporting

Comprehensive knowledge of 21CFR, NDA, IND, ANDA, PMA, 510(k), IDE, FDA guidance documents, ISO standards, ICH/GCP, MDD 93/42/EEC, International Regulations, eCTDs and Adverse Event Reporting (AER)

Understanding of PMDA, Health Canada, ANVISA, TGA, CDSCO

Proficient with SAP, Agile, MS Office Suite (Word, Excel, PowerPoint), Adobe Acrobat

Strong communication, writing, presentation, management, organization and strategy planning skills

Possess meticulous attention to detail and able to follow precise instruction

PROFESSIONAL EXPERIENCE

Nestlé (FMCG Company) Feb’12 – Jul’13

Nutrition Officer (Infant Nutrition Department)

Ethically promoted Nestlé’s Nutraceuticals in the territory by clearly communicating with health care professionals

Ensured recommendation for the Nestle nutrition product range within the scope of the Indian Code/WHO Code for infant feeding practice and infant nutrition

Resolved consumer complaints with minimum lead time

Worked with the cross functional teams to ensure proper distribution and marketing of the product

Assured quality execution in full planning, organization, and management of national-level symposiums as per company guidelines

Consistently exceeded expectations in field operations, including finding potential clients and achieving sales targets

Kept current on products and their nutritional information and scored 90% or above in quizzes

NabrosPharma Pvt. Ltd. Apr’11 – Dec’11

Intern (Quality Assurance Department)

Designed SOPs and reviewed protocols for validation runs

Followed GMP and GLP guidelines to perform quality control tests on drugs and prepared CAPA reports

Verified quality control papers occasionally and submitted adverse event reports (AER)

NabrosPharma Pvt. Ltd. Apr’10 – Jun’10

Intern (Production Department)

Gained functional knowledge of the drug manufacturing process and GMPs through training

ACTIVITIES

Presented at the 61st INDIAN PHARMACEUTICAL CONGRESS (IPC) in December 2008

Conducted 2 NNIC (Nestle Nutrition International Conference) and various Nestle Nutrition Symposiums during my tenure in nestle

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