Quality Assurance Process Improvement
Resume:
Doneart (Arti) Doksani
*** ********** ****** ********** ** 03103
********@*****.***
SUMMARIES OF EXPERTISE
Project Management Summary
. Lead projects to address gaps in SOP's and Batch Records as per consent
decree plan
. Experience with managing team to ensure the completion of projects prior
to deadline.
. Proficient with PowerPoint, Excel, Word, and Visio.
Quality Summary
. Complete priority CAPA's as per Consent decree plan
. QA review of batch records and SOP's
. Perform QA review of Analytical data as per batch record specifications
. Real time on the floor QA review in the manufacturing suites
. Part of the audit team for the regulatory agencies
. Review completed cGMP documentation prior to QA submission.
. Write investigations and close deviations
EDUCATION
. Bachelor, Biology. Saint Anselm College, 2006
. MBA, Plymouth State University, 2009
POSITIONS HELD
ProPharma Group, Frederick, MD 02/12-Present, Quality Assurance Consultant
Lonza, MA
Responsibilities include:
. Perform QA review of Batch Records and other cGMP documentations
. Real Time on the floor review of Batch records and Logbooks
. Provide QA Support on the floor to address manufacturing problems
. Part of Real time Deviation Initiation team
. Revise and Review QA SOP
. Deviation and CAPA review
. Assist on Lot Disposition packages
. Served as a QA Lot Review representative for an external customer
. Address QA costumer comments
Genzyme Corporation, Allston MA, 12/10 - 02/12, MFG Purification Supervisor
Responsibilities include:
. Complete CAPA's, deviations and process improvement projects as per
Consent Decree Plan.
. Write, revise and review Production Records and Standard Operating
Procedures
. Part of the audit team for the regulatory agencies
. Worked with DeltaV and RS3 automation systems
. Review completed cGMP documentation prior to QA submission.
. Review QC analytical data per Production Record Specifications.
. Manage manufacturing process of two products
. Manage a team of direct reports
. Write investigations for MFG deviations
. Work with Validation to complete RQ and IQ of our equipment
. Work closely with our third party batch certifiers to address
observations.
. Experience with Delta V and RS3
Pfizer Biotech, Andover MA, 09/09-12/10, Biology Associate Scientist
Responsibilities include:
. Manage Tech transfer for clinical trial
. Write batch records for different product campaigns
. Provide technical expertise to the Manufacturing team
. Review batch records and data to ensure full flawless completion
. Process Improvement Projects
. Worked with SCADA and HMI systems
Wyeth Biotech, Andover MA, 11/06-09/09, Sr. Purification Technician
Responsibilities include:
. Work closely with validation and engineering during the start-up project
. Assist during the validation and commissioning runs
. Write and revise batch records and SOP's
. Real time review batch records in the Manufacturing suites
. Address QA corrections and questions
Contact this candidate