Sr. Quality Assurnce

SWETA PATEL

U.S. Permanent Resident

** **** ***** ****, ******, NJ, 08830

Cell: 732-***-****

Email: acxe45@r.postjobfree.com

PROFESSIONAL EXPERIENCE:

1)Sr. QA Compliance, Leading Pharma, Fairfield, NJ (April 2016- Till Date)

Final Batch Release and Final Commercial Product

Annual Product Review

Handling of Deviation, Incident reports, Change controls

Preparation and Implementation of Standard Operating Procedures

Experience regarding Controlled Substance drugs

Ensure cGMP Compliance

Support to Regulatory Affairs by providing the necessary documents and information for submission purposes and others if any

Perform documentation control checks

Trainer

2)Sr. QA Associate, APPCO Pharmaceuticals Corp, Somerset, NJ (Oct-2012 TO April 2016)

Handling of Deviation, Incident reports, Change controls, out of specification reports etc…

Review of Batch Records

Preparation and Implementation of Standard Operating Procedures, Stability Protocols, Master Batch, Production Records, etc.

Stability Management

Trainer

Internal audit

Ensure implementation of cGMP, GLP and GDP

Monitoring processing and laboratory activities in the facility on a daily basis

Hosting regulatory audits

Evaluation and Qualification of vendors for raw materials, packaging materials and contract services

Sampling of raw/ packaging materials, in-process samples, finished products, reserve samples and stability samples

Review of analytical material release data & documents and method validation protocols and reports Preparation and review of master and executed batch manufacturing and packaging records

Assigning of Batch Numbers for submission batches

Equipment, Area/Room line clearances for manufacturing/packaging

In-Process Quality Assurance checks during manufacturing and packaging

Monitoring of submission batches & stability studies.

Collection and maintenance of stability samples and execution of stability protocols

Submission of all necessary documents to Regulatory Affairs

Swabbing equipment for cleaning verification

Perform documentation control checks

Issuance of item codes, labels and controlled & uncontrolled copies of documents

Storage, retrieval, control and retention of all completed documents

HONOUR:

6th rank in Rajiv Gandhi University of Health Sciences Karnataka, India (For Master in Quality Assurance)

EXPERIMENTAL TECHNIQUES/ SKILLS:

FTIR, UV/Vis Spectroscopy etc..

Tablet Punching machine, Karl Fischer, Brookfield viscometer, Friabillator, Tap density apparatus, Hardness tester, Blender, disintegration apparatus & Dissolution Apparatus etc...

Proficient in Microsoft Office 2003/07/10

EDUCATION:

Master in Quality Assurance, Rajiv Gandhi University of Health Sciences Karnataka, India, May 2012

Dissertation Title: “Evaluation and Comparison of Cleaning Method Validation Techniques”

Bachelor of Pharmacy, Rajiv Gandhi University of Health Sciences Karnataka, India, Aug 2009

PAPER PUBLICATION:

1.Sweta Patel* “Evaluation of cleaning method validation techniques of Ciprofloxacin”. International Journal of Pharmaceutical and Chemical Sciences 2012; 1(3):1118-1127.

2.Sweta Patel* “Evaluation of cleaning method validation techniques of Pioglitazone”. International Journal of Pharmaceutical and Chemical Sciences 2012;1(3):1143-1153.

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