VIDYA GADAMASETTI US Citizen

Tel: 650-***-**** (Res) 650-***-**** (Off)

E-mail: acui79@r.postjobfree.com

https://www.linkedin.com/in/vidya-gadamasetti-1917531

Career Summary

Pharmaceutical/ Biotech Quality management professional with over 15 years experience in product development and operations. Managed a team of 5-10 professionals and led projects to successful completion. Accomplished, and outcome driven, with continuous success in leading challenging activities with emphasis on overall Quality/FDA compliance improvement.

Specialties:

QMS, Quality System Regulations (QSR), 21CFR 210, 211 and 820, cGMP, ISO 9001, ISO 13485, ISO 14971, SOP (writing and revising), Design control, CAPA/Discrepancy/NCMR, Compliance improvement initiatives, Gap and Risk analysis of Quality Systems, Regulatory compliance requirements, Internal and external audits, Project management, Lean Six Sigma, Method transfer, Validations, and Method Development.

PROFESSIONAL EXPERIENCE:

Thermo Fisher Scientific Oyster point CA

Sr. Quality Engineer

Apr 2012-Present

Support the New Product Introduction (NPI) by providing Design Control support to the development teams. The products developed are Medical Devices and in-vitro diagnostic kits and/or devices and reagents for Research Use only (RUO). Author and approve Design control deliverables. Responsible for maintaining the DHF documents and procedures and completing all required activities to ensure the current and compliance status of the DHF documents throughout the lifecycle of the products. Ensure that the new product development is based on customer requirements.

Implement device risk management program based on ISO14971 and Device Design Control program based on ISO13485 and 21 CFR Part 820.

Provide guidance and decisions on product development activities to ensure continued compliance with internal procedures and applicable regulatory and international standards.

Provide guidance and coaching for post market product sustaining activities such as Design changes and CAPA.

Provide training on Design Control per ISO 9001 ISO 13485 and 21CFR 820, to multiple global sites at Thermo Fisher Scientific.

Provide guidance for Market Specifications, Functional Specifications, Design Verification and Validation, Test Method Validation, Failure Mode Effects Analysis and Design Reviews, using Design Control guidelines.

Collaborate with partner groups across global sites to ensure production, testing, release, and regulatory submission timelines are achieved without compromising product quality.

Proactively work with technical development teams, commercial counterparts, and senior management to identify and escalate project quality risks with the goal of delivering a robust process appropriate for commercial filing acceptable to regulatory Authorities and customers and provide reliable products after launch

Novartis Emeryville CA

Sr QC Scientist Sept 2011-Apr 2012

Responsible for CAPA management and timely closure of CAPAs in Quality Control Department.

Completed and closed more than 40 outstanding CAPAs in the QC Department.

Bayer Corporation Berkeley CA

Asst, QC Manager 2006- 2011

Managed 6-8 analysts in the Quality Microbiology LAL testing laboratory. Ensured timeliness, efficiency, accuracy of testing, and the operations performed were in compliance with company procedures, Quality Standards and cGMP guidelines. Identified procedural and systematic compliance risks and recommended corrective actions. Responsible for prioritizing daily tasks, performance reviews, training, hiring and retaining qualified personnel. Implemented quality measures to ensure compliance with current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).

Achieved cost savings of 100,000 per year, by replacing Rabbit pyrogen testing with validation and implementation of Chromogenic LAL testing. Implemented 40% cost savings by proposing and validating the Turbidimetric LAL for testing water samples.

Directly interacted with FDA and other regulatory agencies during external audits, participated in the internal audit program to identify continuous improvement opportunities. Partnered with other groups (Production, QA, Regulatory and R&D to identify compliance solutions associated with complex processes and new product development.

Managed and improved Quality and efficiency by establishing and implementing new and/or revised procedures, equipment and software upgrades. Represented the department in cross-functional project teams. Provided Quality assessment and testing support on Validation of equipment, systems, processes, and methods.

Supported Organization goals and provided guidance for Quality systems continuous improvement. Initiated and reviewed Change Control documents.

Provided Quality oversight of the internal deviation and CAPA program. Ensured timely review and approval of deviation reports/CAPA plans to facilitate product release and to demonstrate compliance. Conducted and/or served as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to in-process or Final products.

Developed and tracked quality metrics related to product release, deviations and CAPA activities. Worked independently to resolve complex issues. Evaluated and approved engineering and process changes.

Provided technical writing support in the planning, preparation and editing of technical documents in support of regulatory submissions. Worked in a matrix environment to provide data that supported the company business objectives and quality standards.

Supported supplier quality management. Established and maintained cross-functional relations with Suppliers/Vendors, Engineering, Manufacturing, Supply Chain and Regulatory departments for the purpose of Supplier Quality Performance monitoring.

Cell Genesys Inc. CA

Assay Development Scientist 2002- 2005

Designed and optimized biological, immunological, and physico-chemical assays to characterize (vector quantitation, potency, efficacy, and purity etc.) recombinant gene transfer vehicles for Adenoviral vector platform. The techniques used were; Cell based, (Plaque assays) to quantitate infectious titers, immunological (ELISA and Western Blotting) to monitor the immune response of the patients to the virus,

DNA preparation and quantitation by Q-PCR methods, to test for the presence of the virus in the body fluids of the patients.

Supported in-process development and recovery efforts to monitor production methods and vector quantity/yields and performed testing adhering to GMP/GLP regulations.

Responsible for technology transfer of assays to contracting laboratories, Assay service group, and Quality Control Department

Baxter Biosciences Hayward CA

Sr. QC Supervisor/ Principal Immunologist 2000 – 2002

Managed 6 QC analysts in the QC Immunology/Biochemistry testing labs.. Responsible for revising existing SOPs and writing new SOPs when required. Prepared reports and presented the lab metrics to the management on a regular basis. Responsible for review and disposition of data for ELISA, (Mouse IgG) SDS PAGE, and Potency (A280 measurement) assays, for in process, and final container samples.

Responsible for the execution of equipment and method validations, trained analysts on new assays. Represented QC Immunology department, and interacted closely with QA, production and purification departments.

Strove for Operation Excellency by cutting down unnecessary tasks.

Attended and participated in management and leadership seminars and workshops.

Genentech S. San Francisco

Sr. QC Associate 2000

Performed SDS PAGE assays followed by silver staining for testing product purity, and Western Blotting for product stability. Performed ISO electric focusing (IEF) in thin layer poly acryl amide gels to analyze proteins that are separated into iso forms according to their net charge in a stable PH gradient.

AMGEN Thousand Oaks, CA

Assistant Supervisor/ Senior QC Associate 1997-1999

Performed SDS PAGE assays followed by silver or Coomassie blue. Slot blot Hybridization for Quantitation of host cell DNA in the final product. Performed isoelectric focusing in thin layer poly acrylamide gels to analyze proteins. Determined total protein concentration by UV absorbance and by Bradford colorimetric assay. Performed Iso-enzyme profiles of cell lines to verify species.

WYETH-AYERST RESEARCH Princeton, NJ.

Scientist II 1992-1997

Established Smooth Muscle Cell Proliferation Assays (Both Growth Factor and Mitogen Driven) using modifications of published techniques, to evaluate Wyeth-Ayerst compounds for drug discovery in Atherosclerosis and Restenosis Project.

EDUCATION

*Credits towards Ph.D., Department of Zoology, University of Vermont,

*M.S.-Animal Physiology - Osmania University, India

*B.S.-Biology - Osmania University, India

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