SHATRUGHAN DAWANI

adq0ij@r.postjobfree.com

Monroe Township, NJ 08831 Cell 845-***-**** /Home 609-***-**** Summary:

Extensive experience in the Pharmaceutical Industry as a Quality Assurance and Research & Development Professional. Excellent expertise in QA related functions like Batch Record Document Review, Audit, Investigation, Root Cause Analysis and Corrective & Preventive Action . Knowledge of FDA Regulations, Regulatory Affairs, Inspection & cGMP Compliance. Education: Avtech Institute of Technology, South Plainfield, NJ .

● Six Sigma Green Belt : Certificate of Completion 2016

● Clinical Research Associate : Certificate of Completion 2016

● Microsoft Office Specialist Certificate of Completion 2016

● Certified Medical Administrative Assistant Certificate of Completion 2019

● National HealthCareer Association Certified Medical Admins Assistance 2019 University Of Indore,India: Master of Science: Organic Chemistry ( Academic Credential Evaluated by IndoUS Technology & Educational Services Inc . Educational Equivalency in United States : Bachelor’s Degree in Organic Chemistry.

Core Competencies Soft Skills:

Personal Attributes enhances interaction & Performance Meaningful Interpersonal Relationship to work cooperatively. Good Communication,Efficiency, Team Spirit.

Creative Positive Thinking, Optimistic

Analytical Problem Solving Approach

Honesty, Integrity, Dependability

Flexibility & Adaptability, Listening Skill, Respect for others. Work Experience:

AuroHealth, Lawrenseville, NJ

Quality Assurance Associate May 2020 - January 2021 Review and check of Raw Materials Packaging Components Semi finished Brite stock Finished Products

Check Inspect all Active Inactive Ingredients code# Lot# Retest Date Expiry Date Gross Wt to give Line Clearance prior to start Manufacturing process, check all Process S.S tanks Mfg/transfer Tank. Prior to this all checks to undertake for Dispensing in Pharmacy. After completion of Mfg process Sampling of Liquid /Suspension is done with sampling thief for submit with Quality control Lab to check pH /Specific gravity of solution after positive result line clearance for filling liquid in cGMP clean implemented environment,

Perform Inprocess check Weight and Volume of Filled Bottles, Challenge test Induction Sealer to give Start Up for filling and periodic Inprocess check till Brite stock is done or simultaneously In process of final packed is performed as per parameters and specification, Control Samples, Stability samples or additional samples as per protocol/BPR are collected.

if any Process Method Change,Equipment or in Batch Mfg Record, facility or formulation routed through Change Control Procedure

if product not complies, non conformance out of Spec, Investigation is to be conducted determine Root Cause Analysis and Initiate Corrective and Preventive Action ascertain effectiveness and its timely closure .

If any Deviation Planned or Unplanned initiated by originating Department to be examined find justified and approved, assign Deviation Number, get comments reasoning justification to implement and approve, procedure to follow as per SOP in closure within stipulated time. OnBoard USA Services, East Windsor, NJ

Client worked for - AuroPackaging, (Aurobindo) East Windsor, NJ R&D Lab Technician, Packaging Operator November 2019 - May 2020 Set up Packaging line and Equipment includes startup of batch obtaining packaging specification

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Maintain packaging line, inspect line and equipment wear or malfunctioning parts evaluated and report to production manager.

Follow company policies cGMP and Standard Operating procedures, environmental requirements Make any machine adjustment necessary during the production run as needed. Perform In process checks during packaging process and documents in packaging batch record . Make sure all paperwork is complete and accurate throughout and after run. Appco Pharma, Somerset, NJ

Quality Assurance Compliance November 2016 - May 2018

● Review of Batch Manufacturing Records.

● Reporting, Investigation & management of Incidents and Deviations.

● Initiation evaluating,Implementation and reviewing Change Control system,Operation Documents, Facility and Procedures.

● Reporting, Tracking & Management of CAPA.

● Review Process Validation Program, Protocols Compliance, Monitoring cGMP,and its documents, OOS/OOT,Non conformance management.

● Sampling of Raw Materials, Packaging components, Blends, Core, Coated tabs, Finished Products.

● Annual Product Quality Review, Issue and Control of Batch Production Records and acceptable Quality level Determination and Assessment.

● Monitor each operation to assure compliance with document instruction,SOP,s,GMP,s OSHA FDA,DEA and Company Policies

● Audit to assure release of properly cleaned equipment before Use, Swab test, ensure cleaning procedure properly logged.

● In Charge of group of Personnel verify that all QA activities performed in accordance with specifications and laid down parameters

Aspire Pharmaceuticals, Somerset, NJ

Quality Assurance Associate, November 2011 – July 2015

● Calibration of weighing scales and balances TOC analysis, viscometer, texture analyzer, metal detector and other equipment.

● Performed swab sampling of the equipment between product changeovers, rinse sampling of fill preparation vessel for cleaning verification.

● Assisted in QA for customer and regulatory audits.

● Reviewed and approved executed batch records.

● Performed CAPA by analyzing quality data. Root cause analysis was performed by identifying the problem. Action plan implemented to meet the specifications and deadlines.

● Performed further analysis on batch records that were deviated from quality assurance standards.

● Performed thorough check of the various parameters for the Batch Mfg Record.

● Coordinated with external groups and contractors on the validation process for HEPA testing, air velocity and particle monitoring standards.

. Hands on Experience with 21 CFR Part 111 .

ADH Health Products Inc., Congers, NY

Quality Assurance Associate, April 2007 – August 2011

● Reviewed raw materials, packaging and finished goods specification for cGMP compliance.

● Reviewed and performed batch production cycle prior to the release of packaging.

● Drafted and created new SOP’s. Modified and revised existing operational procedures.

● Performed internal cGMP audit checks with observation and findings for corrective actions.

● Sequenced and carried out accuracy checks prior to the production cycle.

● Monitoring physical parameters during compression and encapsulation.

● Sampling is performed for any quality defects. Analysis and AQL attributes are in line for the acceptance/rejections criteria.

NutraMed Packaging Inc., Rockaway, NJ

Quality Assurance Inspector, June 2006 - March 2007

● Investigated all equipment used in the manufacturing process.

● Monitored and checked all active and inactive raw materials components used in the production process.

● Verified all incoming packaging materials according to the SOP requirements.

● Followed all standard operating procedures to provide the room for packaging line clearance.

● Ensured all cGMP compliance and FDA regulated norms and written procedures were followed.

● Developed protocol and complied with all instructions laid down in batch record. Amneal Pharmaceuticals Corporation, Paterson, NJ

Chemist, Research & Development, July 2005 - March 2006

● Developed and worked on generic, ethical, and over-the-counter tablet formulation involving low dose actives, directly compressible dry blends and film coating.

● Responsible for maintaining documentation for experimental batches, process engineering and stability/bio-equivalence batches including in coordination with relevant departments.

● Performed blending, milling, granulation, drying and tablet compression, performed physical parameters and powder characterization studies executed new products from prototype formulation to robust scale up manufacture commercial batches, validation, equipment qualification IQ, OQ & PQ. Ensured and worked in accordance with cGMP .SOP,s OSHA, and EPA compliance, FDA Regulation

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