Quality Control

Neemi Tiwari

#***, ***** ******, ********** ******, punjagutaa, Hyderabad Pin-500082

Mob: +91-916******* E-mail: *****.******@*****.***

CAREER SUMMARY

A seasoned professional with nearly 4 years rich experience.

Currently designated as Executive ,Quality Management System with Aurobindo Pharma Ltd., A.P.

Previously in Macleods Pharmaceuticals Limited, HP as QA Officer .

ORGANISATIONAL EXPERIENCE

Since Nov’11 at Aurobindo Pharma Limited

Executive-QMS

My responsibilities are as follows: -

• Responsible for preparation, tracking and closing of Change Control, PNC, Exceptions (Deviation), MNC( Material non-conformance), CAPA, Market Complaints, OOS & Quality Risk Management Reports

• Responsible for coordinating for Annual product quality review for drug product.

• Preparation of Quality Trends , Data collection and preparation of Monthly Review Meeting & Quality Risk Management.

• Review of Regulatory Observations .

• Team member Audit Compliance .

Audits Exposure at Aurobindo Pharma Ltd.

UK –MHRA

Fimea-Finland

Since July 07 – April’11 at Macleods Pharmaceuticals Limited

Sr. Officer - QA

• Line Clearance in core areas ( Dispensing,Granulation, Compression, Coating)

Inprocess - Checks.

• Review of Process Validation Protocols.

• Execution of Process Validation.

• Execution of Hold Time Study at Granulation, Compression and Coated tablets.

• Reporting Non- conformance in the manufacturing area.

• Checks in Control Sample area .

• To review Batch manufacturing and packing record.

• Timely review of batch records for the preparation of Annual Product Review.

• Interaction with Quality Control, manufacturing and other functional areas.

• Handling of Change control and Deviations.

Audits Exposure

Pre USFDA

MCC-SA

GSK

Diploma Course in Regulatory Affairs Aug.2011-Oct.2011

• Regulatory requirements for U.S. Market

• Regulatory requirements for European Market

• Regulatory requirement of Japanese market

• Knowledge of Marketing Authorisation procedures and submission requirements of above countries along with Canada.

• ANDA submission procedures

• Patents and Patent related details

• Patent challenges ( paragraph IV)

• Knowledge of Risk Management and assessment.

• Recalls statements and types of U.S. and European norms

• Phases and importance of Clinical Trials.

EDUCATION

B.Pharmacy from Govt.College of Pharmacy , Karad, Maharashtra July 2007

Class XII ( CBSE)- Middle Andaman May 2003

Class X (CBSE) -Middle Andaman May 2001

PERSONAL DETAILS

Date of Birth 08 June 1985

Gender Female

Marital Status Unmarried

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