Quality Assurance Control

Anurag Gadgil

617-***-**** ǀ ac0qd8@r.postjobfree.com

LinkedIn contact: https://www.linkedin.com/in/anurag-gadgil-b100a028

Summary

• Highly motivated individual trained in Regulatory Affairs and Pharmaceutical Sciences with industry experience in drug manufacturing (cGMP and cGLP) and formulation, Complaint handling, quality control, product packaging and labeling, healthcare provider accounts

• Demonstrated ability to communicate with and mentor diverse groups in industrial and academic goals

Work Experience

Quality Assurance Specialist Nov 2016 – May 2017

Imugen- An Oxford Immunotec Company Boston, MA

• Conducted and supported comprehensive internal audits including audit scheduling, audit preparation, audit execution, audit response/resolution, and audit follow-up by collaborating with internal/external business partners. Participated in a FDA audit for a submitted BLA submission.

• Initiated, documented and conducted follow-ups on deviations, non-conformances, CAPAs and change control.

• Performed Suspect Product Investigation for incoming raw materials

• Accomplished efficient and effective quality review of procedures packaging documents, test methods, specifications, batch records, annual product quality review, validation studies, protocols, risk assessments, reports, IQ/OQ/PQ documents, validations and provide professional and objective feedback based on the results.

• Supported continuous quality training including quality training as per annual regulatory training requirements

• Interacted with the manufacturing and laboratory personnel to ensure cGMP compliance

• Document Control: Facilitated process for new, revised and obsoleted documents along with tracking for status through document control software (Q-Pulse).

• Supported validation of laboratory procedures, collect and analyze data, and perform routine document review.

• Prepared, Regulated and reviewed product labeling along with APPROVAL and QUARANTINE labels.

• Reviewed Regulatory Complete Response Document which answered questions received from the FDA.

Regulatory and Quality Assurance Associate Jan 2014 – July 2014

For SEPPIC Inc. Mumbai. India

• Led an industrial research project involving analysis, validation and regulatory support for a new coating polymer to meet standards for timed release of drug in a tablet formulation

• Assisted in creation and review of SOPs

• Assisted in compilation of regulatory submissions like NDA, ANDA, IND, BLA and applicable supplements for international market

• Performed Quality Control and Quality Assurance testing of manufactured batches and maintained the documentation for the same. Reviewed labelling for compliance with applicable country regulations

• Participated in many trouble shooting sessions. Assisted in resolving product complaints and providing CAPA.

Medical Coder Aug 2013 – Nov 2013

GeBBS Healthcare Solutions Mumbai, India

• Interfaced between the medical administration and insurance companies to ensure reimbursement to the treating doctor. Utilized ICD-9-CM guidelines or classification, CPT codes, medical terminology

• Generated case files based on treatment procedures, diagnostic codes and coding guidelines and standardized

Procedures for medical claims reimbursement

Quality Control and Quality Assurance Trainee (Internship) May 2012-Aug 2012

Novartis (Sandoz) Pvt Ltd Mumbai, India

• Verified that the products are manufactured and packaged according to the internal SOPs and compliant with FDA guidelines

• Evaluate Batch Manufacturing Records

• Supported with back-up assistance to the submission team as a power user

• Actively involved in compiling submission and support management projects and initiatives.

• Operated in supervision of a senior level regulatory staff to ensure the compilation and maintenance of submission and observed compilation of Material Safety Data Sheets (MSDSs) data and Standardized Raw Material Information Form (RMIF) for meeting deadlines

• Devised formulation protocols for phases of manufacturing of tablets

• Coordinate and review documentation received from cross-functional team members for accuracy,

completeness and to ensure compliance with applicable regulations and requirements

• Observed and assisted with the complaint handling

Education

Masters in Regulatory Affairs and Health Policy Aug 2016

MCPHS University Boston, MA

GPA: 3.822

Case Study Thesis: “Evaluation and determination of the relationship between the regulatory risk and objective evidence required for a de novo submission”

Course work: Quality Assurance (cGMP, CMC, ISO, ICH), Medical Device (PMA, 510(k) submissions, Modules, Design Control, CAPA), Health Epidemiology, International Regulatory Affairs (BRIC, ANVISA, Health Canada and EU). Knowledgeable about ANDAs, INDs, NDAs, IDEs, CTDs; along with TSC Act and EHS regulations

Bachelors in Pharmacy June 2013

University of Mumbai Mumbai, India

GPA: 3.57

Coursework: Pharmaceutics, Pharmacology, Medicinal Chemistry, Biotechnology, Pharmaceutical Analysis

Regulatory Technical Acumen

Drugs and Biologics: pre-IND, IND, DMF, NDA, BLA, MAA, ANDA, ANVISA, Regulatory Submissions

Medical Device: 510(k), IDE, PMA, De Novo, QSR, UDI, MDRs, MDVs, ISO 13485, ISO 14971, DMR, DHR, DMF knowledgeable about CLIA, WMTS, OSHA/WISHA

Compliance Audits: FDA Form 483, Warning Letters, Consent Decrees, GMP, GLP, GCP, QbD, CAPA, 21 CFR and Labeling compliance, Informed Consent, Protocol preparation and review

Software: Laboratory Information Management System (LIMS), SAP, Microsoft Office Suite (Word, Excel, Outlook and PowerPoint), Adobe Acrobat, Trackwise, Q-Pulse

Professional Development

• Harvard T.H Chan School of Public Health, Training Program at Institutional Review Board (IRB) review meeting

• Graduate Students Association (GSA) - As a Treasurer

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