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Quality Assurance Microsoft Office

Monroe Township, New Jersey, 08831, United States
October 02, 2016

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Shatrughan Dawani

Monroe Township, NJ 08831



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

Word, Excel, Power Point, Outlook, Share point

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 co-operatively.

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:

Aspire Pharmaceuticals, Somerset, NJ

Quality Assurance Supervisor, 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 change overs, 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 Supervisor, 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 procedure 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, SOPs, OSHA and EPA compliance and FDA regulation.

Able Laboratories, South Plainfield, NJ

Quality Assurance Inspector, January 2005 - May 2005

Responsible for QA inspection of equipment and process validation of batches.

Ensuring booth clearance of manufacturing area and packaging line in tablets, capsules and suppositories.

Retained knowledge of 21 CFR, part 210&211, cGMP for Pharmaceutical Manufacturing, Processing, Packaging and Holding of drugs.

Conducted physical defect analysis to ensure acceptable quality level.

Checked product physical parameters i.e weight variation, and hardness, and thickness, friability to maintain and ensure required specification.

Biopharm Inc., Levittown, PA

Pharmacy Production Assistant, July 2004 - December 2004

Responsible for balance calibration, weighing of bulk drugs of solid dosage and liquids for complete batch process /manufacturing keeping inventory control of active/inactive raw and packaging material.

Shipping and handling of incoming/outgoing raw material, packaging components, and finished products, and review of batch record, related documents to production and lab standards.

Assisted liquid formulation involves solubilization methodology.

Resolved manufacturing issue of polymorphic behavior of coca butter

Immigration Status:

US Citizen

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