Sweta J. Patel

201-***-****

adujsl@r.postjobfree.com

MASTER IN INDUSTRIAL PHARMACEUTICAL SCIENCE, LONG ISLAND UNIVERSITY, NY, 2009-2011

EDUCATION

BACHELOR IN PHARMACY, INDIA, 2007

COMPUTER SKILLS: MS-Office 2013, CAT 1 certificate, Chem Windows

HPLC SOFTWARE: Empower, ChemStation, Open chrome familiar with HPLC Chromatography data system.

INSTRUMENTS HANDLED:

UV - SEPCTROPHOTOMETER (Shimadzu) PARTICLE SIZE (Haver-Tyler 200 Digital T, Airjet)

FTIR: (Shimadzu) DISSOLUTION APPARATUS (Vankel, Varian)

Karl Fischer (Moisture Determination) Disintegrating Apparatus

HPLC (Shimadzu)

PROFESSIONAL EXPERIENCE:

GLENMARK PHARMACEUTICALS,Monroe,NC

Microbiology analyst and Regulatory associate October2020 -continue working

Knowledge of regulation for US FDA submission.

Review, edit and submit regulatory documentation.

Compile regulatory documents for FDA and electronic CTD submission.

Experience with FDA AND ICH Guideline.

Experience to write and revise SOP and making protocol using technical knowledge.

Adprom experience and experience with word processing,excel spreadsheet,database and online research.

Ability to work with multiple project and problem solving.

Editing,formatting and helping comment resolution on briefing documents or drug application for regulatory pharmaceutical product.

Excellent analytical ability, strong communication skill and effective attention to details.

Preparation of Revenue and Capex Budget as per spent analysis project. Ensure financial

prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.

• Maintain quality system controls to ensure no critical and major market complaints.

• Ensure that all statutory and regulatory compliance are regularly monitored and is in a state of compliance as applicable.

• Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency.

• Monitoring samples, in-process product samples, raw materials, and environmental monitoring (EM) samples.

• Count colony forming units (CFU) on Petri plates.

• Perform sterility testing on final products and raw materials.

• Perform Growth Promotion and Biological Indicator testing.

• Perform preparation of reagents, materials, and equipment used in microbiological testing in sterile environments, such as HEPA hoods.

• Maintain accurate and complete test records.

• Help maintain inventory by reporting needed supplies.

• Enter test results in the Laboratory Information Management Systems (LIMS).

• Maintain sample logs on a daily basis to ensure timely testing and tracking of all samples.

• Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.

• Maintain current knowledge of regulatory and industry standards, trends and advancements.

• Preparation, review and approval of sampling matrix and hold time schedule Conducts and communicates results of lab investigations when test results fall outside pre-established specifications (OOS).

• Performs routine equipment maintenance.

• Performs maintenance of spare parts inventory, calibrations and supervises third party maintenance and repair when necessary.

• Establishes good working relation with contract laboratories.

• Supports in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ protocols.

• Supports activities regarding audits of suppliers and contract labs in support of vendor certification program.

• Conducts statistical evaluation of the manufacturing and inspection process and training QC staff.

• Assures laboratory databases are maintained and accurate.

• Ensures control of laboratory documentation (Raw Material COA, testing instructions, testing.

• Ensure that all equipment is calibrated.

EXELA PHARMASCIENCE, LENOIR, NC

Technical data reviewer july-september 2019

The Technical Data Reviewer is responsible for reviewing and approving technical documents such as method validation/verification protocols and reports, raw material testing, release and stability test data sheets and laboratory notebooks.

Job Responsibilities

•Review and approve IQ, OQ, and PQ documents for all analytical instrumentation such as FTIR, HPLC, GC, AA, and UV/VIS, and have a scientific understanding of these techniques.

•Review documents that support incoming raw material and component release.

•Audit and ensure all activities are performed in compliance with cGLP/CGMP requirements.

•Review investigations on studies that have unusual results, and on out-of-trend and out-of-specification results.

•Write, review, and update standard operating procedures and department policies as needed.

GREINER BIO ONE, MONROE,NC

Quality Control Data Reviewer, Jan 2018-Feb 2019

•Review device history record and associated QC test record for completeness and verify accuracy of the record.

•Provide compliance review of incoming goods inspection form,equipment logbooks,test record,quality irregularity reports,solution prep documentation and laboratory notebooks for quality control.

•Collaborate with QC and Production to resolve DHR discrepancies or errors as related to Good Documentation Practices,SAP inventory or product release to market.

•Organizing,filing and archiving DHRs,QIRS and other quality records.

•Preparation,editing and publishing of test procedures, standard operating procedures and other applicable quality documents.

•Review and approval of QC documentation.

•Review and release DHRs and sterilized product.

•Perform final release of product and reviewing of documents according to valid TPs and SOP s as required.

•Carry out QC testing and inspection according to valid procedure, as required.

•Experience with GMP and GLP environment following ICH Guideline and FDA Guidelines.

•Technical understanding of GOOD Documentation Practice.

BLUE STAR SILICONES USA CORP. YORK, SC (Contract position)

Research Assistant, Feb 2017-July 2017

•Solve process or formulations problem using laboratory equipment and complete projects or assignments of limited to moderate scope and complexity.

•Carry out technical assignments that are initiated by other chemists and records data, observations and conclusion.

•Actively participate in site safety activities and do demonstrate a commitment to help the site achieve an incident free safety culture.

•Ability to work independently within the established guidelines.

•Basic knowledge in lab chemistry terminology and practices.

•Ability to analyze data and process information.

•Working knowledge of Microsoft Office including Word, Excel and PowerPoint.

EI PHARMACEUTICAL WORK SOLUTION, Kannapolic, NC, 2016

QC LAB TECHNICIAN

•Solve process or formulations problem using laboratory equipment and complete projects or assignments of limited to moderate scope and complexity.

•Carry out technical assignments that are initiated by other chemists and records data, observations and conclusion.

•Perform analytical testing and documentation using primarily viscometer, pH meter, UV-Vis, FTIR, titration and KF as well as wet chemistry in a CGMP environment.

•Prepare test solution and mobile phase.

•Document all testing and other activities in proper logbooks, prepare reports and generate spreadsheets as needed.

•Work on multiple projects simultaneously and special projects and other duties as assigned.

•Ability to understand basic math and to understand scientific principles of analytical instrument and testing.

•Interact closely with production, R&D and QC in an atmosphere which encourages the open and constructive exchange of idea.

•Excellent writing skills. Word processing knowledge of Word and Excel.

•Ability to communicate and interact and external customers as well as auditors.

•Properly dispose of hazardous chemical and waste.

•Assist with material management, inventory, logging and tracking as needed.

•Perform calibration of balance and PH meter.

•Perform basic instrument maintenance as needed.

QUALITY CONTROL CHEMIST, ZYDUS CADILA PHARMA, 2013-2015

•Independently perform complex testing for chromatographic and spectrometric method like HPLC, UV of analysis of known chemical entities.

•Proficient in the use of Empower.

•Approve batches, incoming raw materials and routine analysis of different pharmaceutical samples to classify their physical and chemical identity.

•Performing all chemical tests associated with product stability studies.

•Assist in the investigations of OOS and deviations as requested by the QC manager.

•Notify QC laboratory manager immediately of Out Of Specification results.

•Assist in special projects and regulatory audits requested by QC Lab manager.

•Ensuring new log books, draft technical document.

•Experience with ICH Guidelines.

•Proficient with current word processing, spreadsheets and database software.

•Development of analytical methods using sophisticated instruments, e.g., UV, FTIR, Dissolution Apparatus.

•Validation of analytical methods.

•Testing of in-process, finished product and stability samples per cGMP requirements.

•Training of junior level chemists/technicians on laboratory techniques, sample preparation, instrumentation, documentation, safety, and regulatory compliance.

•Technical understanding of USP, BP and EP methodology.

•Preparation and maintenance of accurate and complete technical documentation.

•Developed and wrote residual solvents methods.

•Performed HPLC assays: affinity, reverse-phase, size exclusion, hydrophobic interact

•Proficient in Dissolution and Dissolution testing stations, GC, Karl Fischer moisture titrators, UV-Vis, Hardness testing, Disintegration and a large variety of other analytical instrumentation and techniques. (E.g. pH meters, DO meters).

•Experience with writing standard operating procedure.

•Experience with GMP and GLP environment following ICH Guideline and FDA Guidelines.

•Gained work experience with coating and polymer.

Contact this candidate