Quality Assurance Management

AASTHA KOHLI, MS, RAC (US, EU)

abjwkf@r.postjobfree.com

Boston,

MA 617-***-****

Available from

January 1, 2013

PROFESSIONAL EXPERIENCE

Regulatory Affairs Specialist (contractor), Haemonetics Corporation, MA July

2012-Current

• Assist in 510(k) (traditional and special) review and submission for Class II blood products using STED

format

• Provide support in review, submission and update of EU technical files and design dossiers for Class II and

Class III products respectively

• Helped in Pre-IDE meeting request preparation and submission of documents for the meeting and worked on

IDE

• Supporting Haemonetics acquisition of Pall Corporation:

US and OUS device registrations and listings;

-

Review labels and IFUs for global regulatory compliance;

-

Apply for DOCs, CFGs/COEs/CFSs, and apostille/legalization;

-

Submit Health Canada device (MDL) and establishment licenses (MDEL);

-

Participate in global cross-functional communication activities

-

• Research regulatory requirements to support global regulatory product registrations

• Assisted in preparing for EU Notified Body Inspection readiness

• Worked on CAPAs and recalls

Regulatory Affairs/Quality Assurance Co-op, Acceleron Pharma, MA Jan’2012-June

2012

• Supported quality systems compliance with FDA and EU regulations and ICH guidelines

• Supported continuous improvement projects in quality department

• Assisted document control, process mapping, risk management, gap analysis and optimization of quality

systems

• Lead the electronic Change Control Management project and created:

- Process mapping

- User Requirement Specifications (URS) and Functional Requirement Specifications (FRS)

- Installation Qualification (IQ) and Performance Qualification (PQ)

- Risk Assessment, Validation Master Plan (VMP), SOP and conducted training

• Involved in the management of change controls, deviation, OOS, NCMRs and CAPA

• Reviewed stability data and batch records

• Assisted supplier quality management

• Supported internal GMP and GLP audits; audit scheduling

• Managed drug product accountability and recalls

• Assisted in reviewing regulatory submission documents for CMC module

Regulatory Affairs/Quality Assurance Intern, Proprietary Products, Dr. Reddy’s Laboratories, NJ June 2011-

Dec’2011

• Supported project management and regulatory strategy group

• Researched and analyzed regulatory requirements to provide updated regulatory information

• Compiled, reviewed and made regulatory submissions (eCTD format) including IND/NDA/ANDA, annual

reports and amendments (including information, protocol and CMC amendments)

• Participated in external GCP and GMP audits and prepared audit reports

• Authored SOPs for quality, regulatory and clinical operations

• Assisted in writing clinical protocols

• Reviewed nonclinical and clinical study reports and maintained TMF

• Drafted regulatory strategy for using social media in prescription drug promotion and advertisement

• Assisted Pharmacovigilance activities: submitting PSURs; receiving, documenting, tracking, investigating

and reporting spontaneous ADEs and 15-Day alert reports;

• Helped in regulatory affairs operations like OPDP submissions, Structured Product Labeling (SPL) and drug

listing

Clinical Pharmacy Practice Intern, HCG Medisurge Hospitals, India Jan’ 2010-

June 2010

• Patient counseling, dispensing, audits, adverse events and medication errors reporting & documentation

Quality Assurance Associate in Production Department, Merril Pharma Pvt. Ltd., India Nov’2008–

Aug’2009

• Provided quality control (QC) support in manufacturing operations of drugs products (tablets, capsules and

ointments)

• Assisted in document control-preparation and archiving of SOPs, batch manufacturing records (BMR),

and internal audit reports in quality assurance (QA) department

CERTIFICATIONS

Regulatory Affairs Certification (RAC) – US and RAC EU

PUBLICATIONS

Aastha Kohli and Shrenik Desai. How Do You Define Regulatory Compliance? Regulatory Focus, July ‘11; 16(7):36-42

Aastha Kohli and Shrenik Desai. Nanomedicine: Current Regulatory Scenario and Prophylactic Regulatory Strategies .

Regulatory Focus, January ’12; 1-7

EDUCATION

M.S. Regulatory Affairs for Drugs, Biologics and Medical Devices, Northeastern University, USA June 2012

Activities: RAPS, DIA and MDG Member (GPA: 3.7/4.0)

Bachelor of Pharmacy Honors, Nirma University, Institute of Pharmacy, India July 2010

Thesis: Clinical Pharmacy Practice Experience (GPA: 4.0/4.0)

Bachelor of Pharmacy, Rajiv Gandhi University of Health Sciences, India Oct’2008

Thesis: Estimation of Hypoglycemic Activity in STZ induced Diabetic Rats via SD and MD studies (GPA: 4.0/4.0)

KNOWLEDGE AND SKILLS

Regulatory Affairs: “In-depth knowledge and understanding of”

• IND, NDA, ANDA, BLA, IDE, PMA & 510(k) submissions including 21 CFR part 807, 312, 314,

• ICH guidelines and Quality by Design (QbD) concepts

• Clinical: GCP and GLP regulations

• Quality: GMP regulations including 21 CFR part 210, 211, 820, ISO 13485:2003, ISO 14971

• Global Medical Device Regulations including USA, Europe, Canada, Asia-Pacific and Latin America

Computer Systems:

• Proficient in Microsoft Word, Excel, Access, PowerPoint, SharePoint, Outlook, Visio, Agile, Oracle, Adobe Acrobat,

Lotus Notes, Master Control, QUMAS, Tarius, Citrix Docubridge and Labelbridge.

Others:

• Multitasking; goal-oriented; outstanding reading, writing, proofreading and editing skills; attention to details; decision

making abilities; proven organizational, analytical, managerial, leadership and interpersonal skills

HONORS AND ACHIEVEMENTS

• Best Graduate Student Award 2012, Northeastern University, USA

• International Student Dean’s Scholarship (Top 5%), Northeastern University, USA

• Recipient of Gold Medal for Academic Excellence (2005-2008) (Top 1%); Recipient of Best Student Award (2004-

2008); Recipient of University Ranks, 2005-08 (Top 3%)

LEADERSHIP ROLES

Event Organization Support, RAPS NY/NJ and Boston Chapter, Medical Development Group (MDG) meetings

Orientation Leader, International Student and Scholar Institute (ISSI), Northeastern University

Event Organization Volunteer, South Asian (Bone) Marrow Association of Recruiters (SAMAR)

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