Quality Assurance Control

VARAD RAGHUWANSHI

**** ********* ***** *** ** Los Angeles CA 90007 213-***-****

********@***.***

EDUCATION

UNIVERSITY OF SOUTHERN CALIFORNIA, Los Angeles, CA Aug

****- *** ****

M. S. in Regulatory Science GPA 3.44/4.0

Relevant Coursework:

Quality: Quality Assurance, Chemistry Manufacturing Control (CMC), Risk Management (tools & techniques).

Regulation: Regulation of Medical Devices, Drugs and Biologics, International approaches to medical product

regulation.

Clinical: Clinical Design & Management.

RAJIV GANDHI TECHNICAL UNIVERSITY Bhopal MP, India Aug

2004 - May 2008

Bachelor of Pharmacy GPA 3.75/4.0

ADDITIONAL INFORMATION

Personal Developments & Achievements:

• Completed successfully USFDA, MHRA, TGA and several customer audits.

• Completed successfully regulatory submissions for class projects like IND, 510K, BLA.

• Experienced in CTD, eCTD, labeling requirements for regulatory submissions, 21 CFR 820, 211, 212, Global

regulations for post-approval changes (PAS, CBE-30/CBE, Annual report, Type I A, I B, II), CTA, MAA, ISO14971,

ISO13485, 3100, 9001, REMS, ICH Q8, Q9, Q10 guidelines, Investigation tools SPC, Pareto charts, Taguchi, ANOVA,

lean.

• Familiar with FDA, ICH, EU, MHRA, TGA industry regulations.

• Promoted twice in a year at Lupin for successful FDA audit and audit compliance.

• Trained manager-level group on SOP of document control (distribution, retrieval, retention and destruction of

documents) as an FDA audit compliance.

Applications: EDMQ, Track wise, ERP-SAP, EBPR, MS Word, PowerPoint, Excel, Access

PROFESSIONAL EXPERIENCE

Amgen INC, Thousand Oaks, CA, US Feb 2014 –

Present

Corporate QA Associate III

• Initiating, Revising and obsoleting RM Specifications, Chance control management, Supplier On-boarding, Approval &

Monitoring, Suppliers performance and criticality assessment.

• Accountable for Investigation reports for Non Conformance processes, CAPA, Root cause analysis, compliant

investigation, Raw Material and component qualification, RM Specification development reports, Labeling control &

approval, Quality Compliance and other related QA operations according to the cGMPs.

LUPIN Pharmaceutical Limited, Mandideep, India Oct 2008 -

Jan 2010 Quality Assurance Officer

• Experienced in management of Regulatory (FDA, MHRA, TGA) and customer Audits.

• Skilled in initiating and reviewing change control, deviation (planned/unplanned), SOPs, OOS(out of specification),

OOT (out of trend), CAPA, Market Compliant investigation reports, FDA 483s & warning letter response, Batch

production records, Root cause analysis (FMEA)(Fishbone), NCR investigation, internal audits, Annual product quality

review, Risk-Benefit analysis, vendor management(approval, Qualification & Audit), Art work, IQ, OQ,PQ,

Specifications (RM,FP,IP).

• Collaborated with R&D, regulatory, production, Quality Control, Ware house.

• FAQs and Troubleshooting for Quality Processes, line clearance, handling of control samples.

Sanchi Nature Cure Treatment and Naturopathy Center, Raisen, India Jan 2010 – May

2012

Lecturer / Research Associate

• Successfully supervised, counseled and audited various research works of products used in naturopathy and other herbal

medicines for the patients of Sanchi Naturopathy Centre. Lectured on Biochemistry and APHE.

USC CLASS PROJECT EXPERIENCE

• IND submission: Responsible for preparing assembling and organizing CMC quality sec. (CTD mod 2.3 &3) for

global regulatory submission of Ibuprofen Capsules for CMC class group project.

• Traditional 510K submission for a Class II medical device (skull clamp): Accountable for Executed and device

comparison summary, substantial Equivalence and Labeling part of the document.

• Study Protocol on a Phase 2, multicenter, 26-week, randomized, double-blind, placebo-controlled, parallel-

arm study for patients with moderate to severe Alzheimer’s disease: Accountable for protocol summary,

SWOT, background, drug description, study objectives and safety (AE &AE reporting) .

• Adverse Event case Report: Developed a high-level analysis of examining the range of ways to handle a case

specific adverse event and how that should affect the operations of the company in various departments.

• Quality Audit Report: Led an audit team to define receiving inspection activities, procedure and documentation.

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