Objective: Seeking a position in the pharmaceuticals/biopharmaceuticals field where I can leverage my GMP experience, utilize my skills and challenge my core competencies.

Training:

1.Fundamentals of Flow Cytometry at Southern California Biotechnology Center, Miramar College: 6 hours training in April 2017

2.Biotechnology Skills Training at Southern California Biotechnology Center, Miramar College: 21 hours hand-on training in PCR, ELISA and Mammalian Cell Culture in October 2015

3.DeltaV™ operator training

Experience:

Biotechnology Documentation Specialist at Genentech Inc (Valpro), Oceanside, CA May 16 – Present

Admin and Trainer of PKM (electronic project room used for project communication, planning, scheduling and management)

Admin and superuser of PIMS Project Delivery Solution

Knowledgeable in TrackWise, IBM FileNet Content Manager and verification of Turn Over Package documentation

Review URS, FS, DS to verify electronic copy against hard copy; this ensures we have the correct electronic copy to generate the test from; verifies hard copy routing for signatures matches approved electronic copy

Review URS, FS, DS to ensure design comments, commissioning incident comments, and deviations are accurately incorporated into the document

Quality check for GMP document; version control, GDP, etc

Generate deviation summaries for Deviation Closure; listing corrective actions and generating attachments

Generate Qualification Summary Reports for qualification protocols and Risk Management Report

Route protocols, RAs, CAs, RTMs, RMRs for pre- and post-approvals

Scan final reports, RTMs, RAs, CAs, and RMRs for Change Records and filing in electronic document repositories

Work with QA Records Management group to submit/scan/retrieve/vaulting of GMP documentation

Maintaining Document Tracking tool

Experienced in taking meeting minutes, Doc Link (Electronic Document Management System), using SharePoint sites

Familiar with AgileDoc® Process Automation Documentation system used by client to generate design documentation for DeltaV™ software configuration

Quality Control Lab Technician at Botanx, LLC, Anaheim, CA Jan 16 – Apr 16

Test raw materials and approve for manufacturing

Operate pH meter, viscometer, hydrometer and moisture balance

Test and approve finished product for quality and conformance to specifications

Ensure outside testing (micro and environmental) is performed in accordance with defined standards

Maintain and calibrate lab equipment

Production scale up from lab scale according to approved formulations and procedures

Create and retain production records per standards

Macleods Pharmaceuticals Limited, Daman, India (Laboratory Experience) Feb 08 – May 08

Operated lab equipment for HPLC, Titration, TLC, FTIR and UV-Vis Spectrophotometer

Tested products/materials for physical and chemical properties, stability and impurities

Performed weight variation testing, dissolution testing and hardness testing for solid dosage form

Macleods Pharmaceuticals Limited, Daman, India (Manufacturing Exposure) Oct 07 – Jan 08

Calibrated metered dosage pumps and documented calibration dates and due dates

Conducted tests for quality (tablet hardness, friability, weight variation and disintegration)

Assisted in setup and operation of tablet press, Hi-coater and capsule filling machine

Operated equipment for weighing/dispensing, wet/dry granulation, blending, drying and tablet compression tasks

Skills:

Regulatory Knowledge: GMP, GLP, GCP, FDA Guidelines, 21 CFR Part 11, 210, 211, 58,

312, 314, 820 Guidelines, NDA & ANDA, OSHA, DEA, ICH Q7, Q8, Q9, Q10 and E14 Guidelines.

Technical Knowledge: Analytical laboratory equipment and processes, UFDF, upstream and downstream process understanding, Validation life cycle, process, cleaning and facility validation, PAT, IQ, OQ and PQ, FAT & SAT, commissioning, qualification of equipment, software and process.

Technical Writing and Review: Knowledge of SOP, documentation and report submissions, deviation resolutions, comment resolution, reviewing documentation to align with standards and guidelines.

Manufacturing Knowledge: Solid and Semi solid dosage forms manufacturing, quality testing of tablets and capsules, calibration of tablet and capsule machine, and metered dosage pumps, cleaning of equipment.

Project Management: Understanding of Project Planning – scope, cost and schedule, planning quality and communications, risk management and monitoring, cost control, change control and closing of the Project.

Curriculum Laboratory Experience: HPLC, GC, FTIR, NMR, Mass Spectrometry, UV-Vis Spectrophotometer, TLC, HPTLC, pH meter, colorimeter, flame photometry, conductivity meter, titration and synthesis of organic compounds, cell culture, preparation of parenteral and microbial colony, gel electrophoresis, staining of bacterial cell wall and identification of various bacteria, ELISA, calculated RBC, WBC and clotting time.

Software: Microsoft Office, online collaboration, organization apps.

Education:

Master of Science in Pharmaceutical Manufacturing (GPA 3.27) Fall 08 – Spring 10

Stevens Institute of Technology, Hoboken NJ

Courses: Introduction to Pharmaceutical Manufacturing, Validation and Regulatory Affairs in Pharmaceutical Manufacturing, PAT in Pharmaceutical Operation, GMP in Pharmaceutical Facility Design, Pharmaceutical Finishing and Packaging system, Engineering Economics and Cost Analysis, Introduction to Project Management for the Pharma Industry, Medical Device Manufacturing, Bioprocess Technology in API Manufacturing, and Design of Water, Steam and CIP Utility System for Pharmaceutical Manufacturing

Term Papers: GMP requirements of the FDA and EMEA, A business case on migration to a fully digital automation system DeltaV, Risk Management for Pharmaceutical Change Control, Small scale Bioreactor for Mammalian Cell Culture, Cell Line Engineering Strategies for production of stable and high-productive mammalian cell lines, Pre-sterilized single use filling systems for liquid pharmaceuticals, Reduction of cancer risk related to ETO sterilization

Bachelor of Pharmacy (First Class) Aug 03 – Aug 07

JSS College of Pharmacy, Ootacamund, India

Courses: Pharmacology, Pharmaceutical Analysis, Biochemistry, Organic Chemistry, Physical Pharmaceutics, Pharmacognosy, Pharmacy Practice, Inorganic Chemistry

Project: “Comparative studies of different extraction methods with the use of different herbal drugs such as Turmeric, Amla and Pepper”http://www.linkedin.com/profile/view?id=106025655&trk=tab_pro

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