Plant Medical Device

Perry Mistry

SvpmtechLabServices:

Laboratory Testing Services:

Feasibility Reports Development Services:

EMAIL: ********@*****.***

Profile:

* 12+ years of US and 21+ years of Global Experience in High Tech

MnfgIndustry:

* Expert in Good Practices (GxP) - GMP, GLP, GCP for Chemical, Medical,

Pharma-Sector applications of PAT process analytical technology studies.

* Extensive experience in Medical Devices Q/C, Q/A, Suppliers Quality

Assurance, Certification & Auditing procedures for pilot laboratory to

manufacturing stage.

* Exhaustive Lab. Supervision/ Hands-on skills in Bio-compatibility- Lab

Instruments operations, Lab-Testing onsite & at certified vendor Labs.

* Associated regulatory compliance work for 510K to PMA / QSR / CFR11 /

HIPAA

* Special skills in Water Pollution, Environmental compliances, Economic

Development Department Permits-county-city-state& SWRCA- RWQCB.

* IT Savvy with Technical writing skills in Word, Excel, PowerPoint and

excellent correspondence and follow up skills using email, phone,

conferencing.

* Good at reporting and presentations, Team-Building skills,support with

interdepartmental & outside vendors, regulatory affairs.

* Haz-Mat Operations 40 hrs, 8 hrs Certification for Biological-Toxic-

Hazardous Chemicals Operations, BSL3 & ABSL3 biological & animal biological

Labs.

Professional Experience:

Bio Device Group, Sunnyvale-CA. April

2004-Current :

Position: Member, Bio Device Group:

Study of technical documentation using Word/Excel/PowerPoint. Lab

Information Management Systems requirements for Device Classification for

filings for 510K, IDE & PMA requirements. Visited Labs to train them on

compliances to meet GxP requirements. Conducted & organized group

discussions to enable understanding of CFR11 and HIPAA for Physicians, New

Product Development at their associate labs.

Macroflux, Alza (J&J). Mountain View, CA

Oct 2006-Current

Position: Manufacturing Pilot Laboratory Tech

Manufacture of Braided Catheters per Manufacturing Process Quality

Instructions.

Nitinol, TFE, Lamination, Mandrel Removal, Balloon Removal, Inspection as

per Finished Goods Specs: New Product Development IQ-OQ-PQ - Validation

Procedures implementation. Kuntz Coating Machine Operations for hydrophilic

chemical coating of catheters. Laboratory instruments operations,

calibration, and process data analysis. In Process inspections and

testing Medical Device Manufacturing Station, Review work as per WI & SOP.

Lab-Testing Services onsite & at vendor sites with in-house staff/Vendor-

contract maintenance staff. Maintained Logs- data records and document

control associated with jobs, Nonconforming Materials, CAPA

Guidant, Vascular Intervention, Santa Clara March 2002-

September 2006

(Nitinol Devices & Components-J&J Fremont, CA.)

Position:

In-process inspection and testing of NiTi tubes, Load software program,

operate Laser Machines as per software program - WI for heart stents of

various Dia. /design.

Performed in process materials compliance as per manufacturing process

instructions.

Laboratory instruments operations to check process parameters, Data Entry,

Document Control,ECO,Operated measurement equipments-calipers, Pin Blocks,

Wall Thickness,Go-NoGo tests,Visual & Microscopic Inspections, Defects

Listing

November 2000/February 2002: SIMS-Laboratory Tech. Semiconductor Analytical

Lab. Charles & Associates at Sunnyvale, CA.

Reviewed client's analysis request, Purchase order request, Sample

preparation & analysis, Data Interpretation, Calibration of Instruments in

Lab. As per SPC

Data reduction, Spreadsheet, Report writing and forwarding Test Reports to

customers.

December 1996/November 2000: Environmental, Analytical Laboratory Tech.,

Electro-Medical/PCB Company, Sanmina, Santa Clara, CA

Chemical analysis of DI, wastewater, plating baths, heavy metals analysis

by Atomic Absorption on Varian/Perkin Elmer A/A. Chemical Laboratory

experiments with process equipments & chemical vendors & worked on

Plant/Project -manufacturing Plant site. Performed Purchasing Functions,

Ordering, and inspection, inventory of laboratory chemicals, Lab Equipments

and glassware. Shipping & Receiving Lab Items, Co-ordination with County-

City Fire Dept/Environmental Enforcement-Pollution Control Inspectors,

Safety Traning/EPA-ERT-hazardous materials training & certification.

Global Experience:

1988-96: Pharmaceutical Liquid Formulations & Tablets Contract Mnfg, India.

Supervised the manufacturing of Technical Grade pesticides and pesticide

formulations. Was responsible for meeting the Contract manufacturing quota

for pesticides for Ciba Giegy, who is a major supplier to countries in Asia

& Gulf.

1982-87 ACC, Tata Consultancy Services and Saudi Company: STST-

KSA{International Contract Manufacturing O/M Mngt, Bombay, India}

Managed, Operated and Maintained the Sea Water Desalination Plant of KRUPS

GmbH. This was 500 MPD plant and was trained in Gulf by the German

Engineers to achieve an optimal efficiency for meeting the purification

standards for drinking water and industrial water. As part of my assignment

managed the plant in Saudi Arabia for almost 5 years. The job involved

travel between India & Gulf Countries extensively.

1975-80 Calico Polyester Fiber Plant, Baroda, India

Coordinated manufacturing operations and maintained quality standards with

production efficiency for Polyester Staple fiber plant supplied by ICI UK.

Was involved in Lab equipment calibration, validation and maintenance to

meet the ICI UK standards.

EDUCATION:

B.S. (Chemical Engg.), Faculty of Technology & Engineering-Chemical

Engineering Dept-MSUniversity-Baroda-India-1975.

Computer Based Training-Semiconductor Mnfg-Technology-San Jose City

College. 2000-2001

ERT- training/EPA certified Phoenix Training Group, San Jose. 1996/2002

Project studies, laboratory pilot plant-medical device-drug delivery

assembly-jobs. Onsite TQM, QC/QA Training.Onsite-1975-2005.

PROFESSIONAL ASSOCIATION:

* Aiche-norcal/ Chemical Engineers-local San Jose/silicon valley-Northern

CA -chapter & ASQ-SCV, IEEE-embs, ACRP-Norcal/local clinical research

professionals association. Active member of student chapters during

University, community college studies.

* Detailed study of Indo-American Business Incubators-sipa, TIE-economic

forum, The Enterprise Network-Incubators at San Jose, Santa Clara, San Jose

Bioscience Center, Environmental Business Incubators.

* Associated with seminars & presentations on "Destination Malaysia" &

"Invest" in Korea, Japan, Singapore, Hong-Kong, and Gujarat State-India.

* Detailed study of Economic Development Dept. proposals for Local city,

county at San Jose-Santa Clara County-Silicon Valley Regional City.

* Stem Cell Research Institute-CA study of local city & county-Silicon

Valley Regional Development Proposals for setting up Research Institute in

CA.

* Pilot Plant Laboratory Trials & Plant Commissioning for recovery of heavy

metals from waste water from pcb waste water monitoring system

development(half hour, one hour,8 hour, Daily,weekly & Monthly Sample

monitoring for regulatory -pollution control compliance.)

* Entrepreneurship Development Course at Technology Venture Corporation-

Fenwick & West -Mountain View-CA: 2004/2005

*Business Consultant Nanotechnology-Clean Technology at California Clean

Tech Institute, San Jose, CA. 2008/2009.

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