Quality Control Manager

SHRADDHA SATASIYA

Address: *** **** ******, *** #*. Brookline, MA – 02446

E-mail ID: **************@*****.***

Cell: 718-***-****

EDUCATION M.S. in Regulatory Affairs for Drugs, Biologics and Medical Devices Sep. 2013 – Present

Northeastern University, Boston, MA

B.S. in Pharmaceutical Sciences June 2008 – June 2012

Gujarat Technological University, Ahmedabad, Gujarat.

WORK NASCENT LIFESCIENCE PVT LTD June 2012 – May 2013

EXPERIENCE Position : QA/QC EXECUTIVE

Responsibilities:

- Maintained in-process quality control by establishing quality system in accordance with

cGMP.

- Prepared annual product quality report (APQR) and batch product report.

- Maintained training records in accordance with SOPs.

- Performed assessment of Deviations, including evaluation, tracking, follow-up, reporting and

trending.

LEO FORMULATIONS PVT. LTD. June 2011 July 2011

Position : Trainee QA/QC

Responsibilities:

- Performed quality control tests like leak test, friability test and stability test for solid

dosage forms.

- Assisted manager in writing SOPs for IQ, OQ and PQ.

Presented a poster on “Production of Monoclonal antibodies and its application in

PROJECTS AND -

therapeutic treatments“ at PHARMAFEST 2011 organized by Baroda college of

PRESENTA-

pharmacy and Parul Institute of Pharmacy

TIONS

- Observed the effect of Heavy metal toxicity on epithelial cell line by performing Trypan

blue exclusion method.

TS

Core Competence: Pharmaceutical Drug Development including pre-approval and

SKILLS -

post-approval regulatory strategy

Regulatory Submissions: Accustomed with IND, NDA, ANDA, BLA, IDE, PMA & 510(k)

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submissions

Global Regulatory Knowledge: Skilled with FDA, EMA, Latin American, Canadian and

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ASEAN Regulations

Quality: Well versed with GMP regulations including 21 CFR part 210, 211 and ISO

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9001.

Computer: Proficient in Microsoft Word, Excel, Access, PowerPoint, SharePoint,

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Outlook, Visio, Adobe Acrobat and FileMaker Pro

References are available upon request

REFERENCES -

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