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Quality Assurance Manager

Location:
Buffalo Grove, Illinois, United States
Posted:
January 13, 2017

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Profile for Ankita Agrawal

acx9sa@r.postjobfree.com

I have 10 years of experience working as a regulatory professional with focus on ANDA submissions.

Over 100+ Regulatory submission (paper) for Generic products Analgesic, Erectile Dysfunction, Anti-Fungal, Proton Pump Inhibitors, Cholesterol Lowering Medication, etc.

Successful Registration of 25+ products in global markets Europe, Philippines, Tanzania, Nigeria, Liberia, Sierra Leone, etc.

Coordinate timely, compliant submissions, prepared for global regulatory agencies, in accordance with the regulatory submission plan.

Sets the submission strategy, including timelines and resource projections according to submission type.

Experience in compiling Common Technical Dossier (CTD) specializing in Module I, II & III for Europe, Canada and United Kingdom (paper submission).

Prepared and reviewed process validation, standard operating procedures, and stability documents.

Excellent communication skills, organizational skills, perform well independently as well as with associates.

Committed to work with a positive attitude

Detail oriented, efficient, reliable, dependable & analytical skills

Self-motivated, team player with positive outlook & excellent time management skills

Experience with US labeling operations

Experience in the Brand and Generic pharmaceutical industry

Experience with ANDA Regulatory submissions

Current with Takeda Pharmaceuticals USA Inc.( Regulatory Affairs Associate), Dec 2015- Present.

Preparing and executing labeling for CNS, PPI products.

Developing, revising and maintaining labeling for commercial products under the guidance of the sr. manager.

Managing and maintaining the consistency of labeling documents in accordance with the company’s style guide.

Initiated and reviewed change requests for ongoing projects.

Responsible for preparing and reviewing the Annual Reports.

Review and compare labels of different companies to ensure consistency in labeling content.

Review and compare CCDS with reference labels and basis labels.

Prepared and reviewed competitor documents to maintain labeling current with industry labeling.

Performing proofreading, and quality checks on newly prepared labeling documents.

Review locked content with FDA Approved label to ensure accuracy.

Responsible for updating the Labeling metric (TRAIL) database for all the labeling updates.

Authoring and updating existing Structured Product Labeling (SPL’s) for drug listing.

Delist the SPL’s from Daily Med.

Coordinating and managing SPL preparation with a third party vendor.

Perform quality checks on the SPL using electronic tools (Docuproof) and manual processes for accuracy and content.

Helped in Establishment Registration Listing

Abbvie (RSC and LEx Administrator)from June 2015-Dec 1015

Assisted in reviewing the Company Core Data Sheet (CCDS) with regards to all existing/relevant updates for various countries round the globe.

Performed Proofreading of Package Inserts and Labeling componenets.

Ensure area & affiliate users have appropriate access to RSC and LEx .

Ensure that area & affiliate users are assigned the appropriate roles in RSC and LEx.

Map submission and approval information received via RSC to records in Launch Excellence for updates.

Create RSC records for distribution of CCDS Updates and other centrally managed product changes.

Carefusion as Analyst, (Medical Devices) Regulatory Affairs International, March 2015 – May 2015

Compiled registration packets for different country registration (international) for Class I and II medical devices.

Coordinate inter and intra-department to prepare the data packets (labeling, Certificate of foreign government)

Updated and managed the tracker as necessary.

To perform the remediation activity as required.

Regulatory Affairs Consultant, (Self-employed),INDIA Jan 2010 – Jan 2015

Supported clients for documentation support SOPs, Process validation documents, Stability documents.

Product registration support by preparing and completing dossiers for markets like Philippines, Tanzania, Nigeria, Liberia, Sierra Leone and other Rest-Of-World markets.

Assisting the projects like dossier preparation, query handling, quality documentation preparation as per the business requirements (regulated and unregulated market).

Liaised with the API suppliers for DMF, CEP, LOA & other mandatory requirements

Resolved issues presented by HA, by communicating with different departments.

Reviewed Validation Protocols, Quality Assurance other technical documents

Worked with clients: LOB International, Aquatic formulations, Adlife Limited, McW Healthcare and more.

Matrix Laboratories (Regulatory Affairs Executive), INDIA, Mar 2009 – Jan 2010

Prepared and submitted dossiers in CTD format in EMEA Markets (regulated market)

Updated SOPs to be compliant with current FDA regulations and guidance

Ensure timely submission of ANDA’s by co-coordinating and supporting the team.

Contributed in preparation of amendments, supplements and post approval variations.

Validation and Documentation as per different countries assigned

Medreich Limited (Regulatory Affairs Executive), Bangalore, INDIA, Aug 2006 – Aug 2008

Planned, prepared and reviewed registration dossiers for regulated market for different dosage form (tablets, capsules, oral suspensions & solutions and injections).

Reviewed Regulatory requirements for various countries.

Product submission and compilation for Europe, Canada and UK.

Manage international audits & review audit reports.

Reviewed Clinical Research Protocol and Report as per the ICH Guidelines.

Nicholas Piramal India Ltd (Process Validation & Regulatory Affairs Executive), INDIA, Jul 2003s – May 2006

Assisted in taking ANDA Batches for USFDA submissions

Contributed for technology transfer of product batches from one site to another.

Prepared and reviewed validation documents as per regulatory requirement and SUPAC guidelines.

Prepared Master formula record (MFR), batch records for Exhibit batches as per regulatory requirement

Prepared, reviewed and performed cleaning validation activity (preparing, sampling and compiling the results)

Documentation & preparation of protocol.

Have presented the validation documents during international audits.

EDUCATION

M.S. in Pharmacy (July 2001 to April 2003)

Shri Govindram Seksaria Institute of Technology and Science, Indore (M.P.), INDIA

B.S. in Pharmacy (July 1996 to April 2000)

Shri Govindram Seksaria Institute of Technology and Science, Indore (M.P.), INDIA



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