Page * of *

Devanshi Desai

• 732-***-**** • adus7e@r.postjobfree.com

Professional Profile

Result-driven, highly skilled professional with a proven history of success leading QA, QC and QS teams. Expertise knowledge in investigating, nonconformance, OOS Laboratory test results, trending analysis. Problem-solving skills, extensive technical knowledge and a hands-on approach to build productive departmental teams. Focused on data integrity and regulatory compliance. Education and Certifications.

P.T Science Sarvajanik college.Surat.Gujarat.India. B.S Chemistry/Physics S.G. University, Surat, Gujarat, India: M.S. Chemistry NY State License, Clinical Laboratory Technologist

• Professional Experience

• Akorn Pharmaceutical: QA Documentation Specialists 2021 August-Present.

• Revise and maintain controlled documents such as SOPs, Forms, Master Batch Records, Specifications, Monographs, and Protocols. Process Document Change Requests. Scan and file all controlled documents.

• Revise, Route, Issue, Scan, and File Controlled documents including SOPs, Forms, Master Batch Records, Monographs, Test Methods, and Protocols.

• Ensure Documentation is processed, formatted, issued, and made effective accurately.

• Coordinate Revision, Review, and Approval of all GMP documents.

• Assign tracking numbers and maintain database for DCRs and CCRs through the lifecycle of the documentation.

• Responsible for all document control function, including document login, tracking, processing, distributing and archiving all GMP documents.

• Maintain, Issue and Review Batch Records to production.

• Create, Issue and Maintain Controlled Forms and Logbooks.

• Scan and File Released Batch Records, Component Test Reports and Raw Material Test Reports.

• Monitor and Reconcile all Controlled Documents

• Administer Document Change Control Process and maintain Document Database

• Provide Metrics (Weekly Metrics, Quarterly Metrics, Corporate Metrics)

• Support other teams in compiling, retrieving and reviewing documents during Mock Inspections, Internal/External corporate audits and Regulatory audits.

• Support product development activities

• Write and revise Standard Operating Procedures (SOPs)

• Amneal Pharmaceuticals: QA Specialists-II 2019 March-July-2021

• Perform Review/released of applicable all incoming raw materials, packaging components and returned goods following detailed written procedures. Preparation of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab. Assigning and verification of expiry date and retest date for all the GMP raw materials through vendor COA and Page 2 of 4

in-house COA. Collection of packaged product samples for annual stability ar monitoring and auditing of label room. in terms of Isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas. Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record. Monitor •

• Review Finished Product batch records for timeliness and accuracy

• •Perform final review of manufacturing documentation and provide support in areas of compliance for batch releases

• Provide lot status updates as requested

• •Document and submit reports and documentation errors to management, for trend and training analysis•

• Provide support to the Compliance and Investigation groups, Quality Assurance- manufacturing floor groups during real time reviews, and also assist other departments with batch record retrieval and filing

• Provide support during internal/external audits, as requested

• Perform additional duties as requested

• Participate in and support continuous improvement activities, maintain a clean and organized work space area to ensure compliance

• Performed Proof reading analysis for the Inserts/labels and Cartons.

• Identified the Gap assessment.

• Disposition of rejected material and returned drug products as per SOP.

• Performs environmental monitoring in accordance with established schedule (where applicable).

• Perform applicable testing and prepare report for customer complaints.

• Other duties that management may assign.

QA Document Specialist, U.S Pharma Nutritionals, North Brunswick,NJ April-2016 to Dec-2018

• Works directly with manufacturing-, packaging- and warehouse- departments to ensure Quality requirements are met.

• Preparing and Reviewing Master Bach Records for All existing and New Product ..

• Reviews Quality System documentation, including Production Batch Records, Finished Product Batch Records.

• Review and Release of Raw Material, Preformed proof reading of Finished Product Labeling,components.

• Conducts GMP and SOP training; Compose and review SOP’s and other Quality documents to ensure GMP compliance; Conduct audits to ensure compliance with cGMP’s and SOP’s.

• Maintain Master SOP binders and Historical SOP Binders (physical and electronic)

• Maintain QA documentation retention areas to ensure documentation is available for regulatory and quality review, as required

• Assist internal and regulatory inspection towards employee training and document support

• Review, approve, track, scan, and file all GMP related documents

• Administrative support towards Product Quality Complaint Process Page 3 of 4

• Provide additional administrative support as required from various department

• Sampling of Raw Materials and Packaging Components.

• Responsible for QA oversight, documentation review and product disposition. Ensures non- conforming product is identified and appropriately controlled, and conforming product is appropriately disposition for use.

• Provides support during Client audits/Inspections; QA Batch Record Specialist. 2010- 2015

ITC/Accriva Diagnostics, Edison, NJ/San Diego, CA

● Reviewed DHRs for all products and accelerated the approval of product releases through the Enterprise Resource Planning (ERP) system thus ensuring product availability for customers.

● Reviewed MFG Batch records for accuracy, completeness, and conformance to quality system specifications prior to releasing product to Finished Goods Inventory.

● Reviewed Analytical Quality Control data ensuring all calculations and procedures were correctly performed.

● Reviewed Quality Control and Manufacturing calibration data and daily qualification data for instruments and machinery to ensure all equipment was correctly calibrated and qualified prior to use.

● Reviewed finished product stability data to ensure accuracy of results and to ensure the stability protocols were correctly followed.

● Facilitated resolutions of discrepancies in DHR quality records, Quality Control records, calibration records, and stability records by working with document preparers to resolve questions, inconsistencies, or issues of missing data.

● Performed In process inspection for the finished good product as per ANSI sample plan. Performed laboratory Service request (LSR) testing for any nonconformance or process failure. Maintained ISO standard of the products in accordance with statistical and control procedures to meet optimal quality requirements.

● Worked with all functions and levels of management to resolved any discrepancy/issue related with Products and Processes. Participated with cross functional teams to improve process efficiency.

● Performed effectiveness verifications on completed non-conformance / CAPA reports to ensure any implemented procedure were effective.

● Assists in the review and release of raw materials for use in the manufacturing/laboratory area

● Reviewes proposed changes to existing Standard Operating Procedures as needed

● Generated multiple engineering change orders (ECO) through change control procedure to effectively address process failures and improvements. Reviewed change orders ensuring the accuracy of test procedures and GDP compliance of SOPs and DHRs..

● Initiated and conducted non-conformance and Out of Specification (OOS) investigations to determine root cause of product/process failures.

● Reviewed and Approved Validation Protocols for the New Product or Existing product development.

● Conducted hands on training to newly hired employees Research Technologist 2003- 2009

NJ Blood Services, New Brunswick NJ 08901

Perform Nucleic Acid Amplification Tests for the West Nile Virus by processing donor samples by operating various automated instrument

● Centrifuging, uncapping and placing into Hamilton racks for pooling.

● Creating pools of samples by operating Hamilton STAR Instrument.

● Storage of samples using freezer works program and also to locate the samples for the pending tests.

● Preparing/Pipeting reagents and controls for West Nile Virus testing. Page 4 of 4

● Review and transmitted donor results and then send results to LIS host computer system Progress.

● Perform quality control testing upon arrival of new shipment for reagents and controls.

● Doing inventory of the reagents and controls on monthly basis.

● Perform daily / weekly and preventive maintenance of the Hamilton, Ampliprep/ Taqman and Centrifuge.

● Performing Cholesterol testing using Chemistry Analyzer Modular P 800 Module. Testing of proficiency samples from New York State Department of Health and College of American Pathologist.

Core Competencies:

● Quality Assurance (QA), Quality Control (QC), Quality Systems Review (QSR), GxP

● Medical Devices, Laboratory Controls, Homeostasis/Coagulation, Manufacturing, Diagnostics.

● ISO/FDA regulation, GMP/GDP/GLP Requirements

●

Equipment and Technical Skills:

● Regulatory compliance: CLIA, FDA cGMP, GCP, GDP, GLP, OSHA, ISO 9001.

● MS Office: Word, Excel, Power Point, Outlook. Visual Basic.

● Track wise. Data trending and analysis. ERP software: Oracle’s JD Edwards Enterprise One.

● Preparation and processing of nucleic acids, blood products, and sterile reagents

● Roche Ampliprep and Taqman Automated Instrument for Viral Detection.

● P-800 modulyzer for Chemistry Testing.

● Hamilton Star instrument for pooling donor samples.

● IBM 2991 blood cell processor.

● Ability to writing/ modify/updating SOPs accordance with the MFG/QC process requirement

Contact this candidate