GAURAV WALIA * SACHEM COURT FARMINGVILLE NY ***** EMAIL: acvgjk@r.postjobfree.com CELL PHONE: 516-***-****

PROFESSIONAL EXPERIENCE

Medtronic, (Black Diamond Networks Consultant)

Campbell, CA 11/2015-4/2016

Focusing on Quality Systems and Regulatory Compliance Systems in the Medical Device Arena.

Performed Full Validation Work, Qualification of Equipment, Full Process Characterization and Test Method Verification (TMV).

In process monitoring and inspection, wrote and executed Full Process Validation Protocols (IQ, OQ, PQ, PPQ) to FDA standards and reports, this included the Cleaning Validation and Product Manufacturing Cleaning Validation.

Ramp up production, quality systems remediation.

Process improvements, lot release, in process improvements, line clearance, train operators, work with supplies.

Trained operators, getting production running and stabilized, work with ops to ramp up.

RCM Technologies/Novartis/Sandoz/Fougera, (Consulting Role)

Manhattan, NY/Melville, NY 04/2015- 07/2015

Site Project/Team Leader – Equipment Qualification, Software Systems Validation and GMP Assessment/Periodic Review.

(Key Focus: United States Pharmacopeia General Information Chapter 1058: Analytical Instrument Qualification, GAMP 5, GMP Assessment, Periodic Review, Standardized Implementation of Key SOPs and Quality Systems Standards for Novartis and Sandoz to Fougera (subsidiary)

Directed a system-wide assessment/periodic review of equipment/software systems for implementation, gap analysis, remediation and corrective action for the aforementioned system in accordance with United States Pharmacopeia (USP) General Information Chapter 1058: Analytical Instrument Qualification, GAMP 5 and GMP Compliance.

Directed and Implemented Domestic and Global Quality Systems Standards for Novartis and Sandoz at Fougera (subsidiary) Facility. Fougera Facility Manufactures Commercial Products such as Sterile Products, solid dosage, creams, ointments, etc.

Conducted Equipment/Software/SOP/Regulatory Systems GAP Analysis and issued Formal Assessment and Periodic Review Report to Executives at Novartis/Sandoz/Fougera.

Drafted and issued Formal Remediation report and CAPA plan for all gaps and deficiencies.

Utilized Sparta Systems’ TrackWise for all CAPA Management.

Additionally, drafted and issued Executive Summary Report and Proposed Budget/Timeline Implementation plan to the Firms Business Units.

Key Leader on Inter-disciplinary teams (such as Business, Quality Assurance, Quality Control, Manufacturing, Microbiology, Environmental Monitoring, Regulatory units) across Novartis/Sandoz and Fougera sites.

Directed assessment and periodic review for adherence to internal and corporate Standard Operating Procedures (domestic/global).

Conducted System wide audit for GMP Compliance, 21CFR Part11, Electronic Records and Electronic Signatures

Conducted multi-departmental site assessment and identification of operational trends and issues in order to mitigate business risk.

Successfully completed all Contract Requirements and Business Objectives prior to Official Deadlines and within budget/resource allocation.

Premier Care industries, Hauppauge, NY 09/2014- 03/2015

Director of Quality Assurance and Regulatory Compliance (Permanent Role)

Reported to the Chief Operating Officer/Part Firm Owner

Directed the Quality Assurance and Regulatory Compliance departments in all aspects of Quality Systems within QA/QC units for all Commercial manufactured products.

Created entire Client Based Quality Systems Programs that were catered to not only cGMP’s but also adherence compliance to FDA Regulations.

Primary responsibility for all FDA Regulatory, Internal and New Potential Client Audits and Inspections.

Experienced in Quality Management System for GMP and Medical Device (for Branded, OTC, and consumer healthcare products) industries including development of required internal procedures in support of ISO 13485, 9000, 9001and 21 CFR Part 820, 21 CFR Parts 11, 210 and 211, etc.

Directed activities related to Investigations, CAPA’s, GAP analyses and remediation

Created Training Programs/Systems and deployed them to the entire organization. Personally trained staff in multiple languages (e.g. English and Spanish).

Responsible for Regulatory Submissions and any formal responses to applicable governmental agencies/regulatory bodies.

Performed System-wide Gap Analysis and Quality System Plan Remediation/Corrective Action in order to ensure that proper Quality Systems were in place and any issues/deficiencies were corrected/had a plan.

Provided overall support to ensure GxP compliance within and across all operational sites.

Augmented the entire Water System Validation, Cleaning Validation and CIP Program in all Commercial Manufacturing Areas.

Primary insight, (a subsidiary of jp morgan chase), New York, NY 01/2003- present

*(Conducting Expert Opinion Advice Services to the Industry – Non permanent/Non-contractual Role. Conducted in my free-time).

Pharmaceutical Industry Expert Consultant – Quality Systems, Global Regulatory Compliance,

Technical Analysis/Guidance, Computer Systems Validation, Disease/Indication Due Diligence, Manufacturing, Technology and Emerging Global Trends.

Existing Panel Member of Consortium of Industry Pharmaceutical Experts.

Utilized and called upon (by Wall Street, Foreign Governments, other major domestic and international financial institutions, and various other pharmaceutical, technical, instrument/equipment, and software firms) for expert knowledge and opinions of various critical aspects of the Pharmaceutical Industry as well as Global Quality Standards and Regulatory Trends.

Provided key Technical, Quality, Compliance, Regulatory, and overall business advice and technical consulting to key members and firms involved in the World Wide Pharmaceutical Landscape/Industry.

Position has been held and conducted in the same capacity for 12+ years. This position also has served as a source of employment and income over last 12+ years during both times of regular employment and during gaps of employment.

guidepoint global, New York, NY 01/2003-present

*(Conducting Expert Opinion Advice Services to the Industry – Non permanent/Non-contractual Role. Conducted in my free-time).

Pharmaceutical Industry Expert Consultant – Quality Systems, Global Regulatory Compliance, Technical Analysis/Guidance, Computer Systems Validation, Disease/Indication Due Diligence, Manufacturing, Technology and Emerging Global Trends.

Utilized and called upon (by Wall Street, Foreign Governments, other major domestic and international financial institutions, and various other pharmaceutical, technical, instrument/equipment, and software firms) for expert knowledge and opinions of various critical aspects of the Pharmaceutical Industry as well as Global Quality Standards and Regulatory Trends.

Provided key Technical, Quality, Compliance, Regulatory, and overall business advice and technical consulting to key members and firms involved in the World Wide Pharmaceutical Landscape/Industry.

Position has been held and conducted in the same capacity for 12+ years. This position also has served as a source of employment and income over last 12+ years during both times of regular employment and during gaps of employment.

McNeil/Johnson and johnson/Quantic/Syndicus Fort Washington, PA 04/2012- 01/2013

Pharmaceutical Consent Decree Consultant

Involved in Computer Systems Validation, Product Quality Management Systems, Complaints, etc.

Lead person of Consent Decree item that specifically involved Computer Systems Validation, specifically in the area of Adverse Events, Complaints and Global Telephony Systems. Initial project involved major upgrade of Global Complaints Systems after which I was extended two additional times for two additional Consent Decree project items.

Successfully completed all three Consent Decree projects and finished projects and software systems were release to the client and were in “GO LIVE” status for global company utilization.

novartis (Validant) Omaha, NE/Los Angeles, CA 3/2012 – 4/2012

Chief Consent Decree Consultant for Quality Systems

Oversee Quality Assurance and Compliance initiatives for Consent Decree Program for Novartis. Conduct Assessment of third party contract manufacturing organizations as well as provided Deviation and CAPA summaries, required Change Controls, Remediation plan, Timelines and budgetary proposal/expenditures. Mainly assessed OTC products for Cold and Cough Liquid formulations for Novartis’ Global Consumer Healthcare Group.

Oversee consent decree initiatives during third party manufacturing assessment in specific technical areas of over Quality Assurance, Quality Control, laboratory and commercial manufacturing equipment and instrument technology as well as applicable software systems.

Executed assessment timelines which were highly critical, thus more than 100 hours per week billable time had been logged into the client. Each week for a total of about 500 + hours during a one month period.

Overall, successfully completed assigned assessment of third party manufacturers for Novartis’ Global Consumer HealthCare Group within the stringent timelines, which were dictated for the project.

B. Braun Bethlehem, PA 3/2011 – 10/2011

Chief Consultant- Consent Decree Regional Director

Oversee Quality Assurance and Compliance initiatives for almost 30 facilities within the USA for large German Pharmaceutical Manufacturer of injectables, IVs, and overall sterile liquid pharmaceutical formulations.

Primary Responsibility to interface with the FDA and FDA approved auditing firms in response to Consent Decree and manage entire Remediation Team, Project Plans and Deliverables.

Provided overall support to ensure GxP compliance within and across approximately 30 operational sites within the sterile injectables, aseptic processes platforms, IV products, etc.

Areas of Key Focus were Facilities and Monitoring Systems, Environmental Control Systems, Microbiological Programs and Clean Room Design/Validation.

Implemented Standard Operating and Quality System Procedures as well the employee training, to ensure both written and hands on procedural knowledge and course effectiveness.

Provided overall support to ensure Consent Decree items, including but limited to, investigations, CAPA’s, GAP analyses, remediation activities, timelines, report issuance and communication to key stake holders, firm executives and the Agency.

Managed activities and overall technical/quality systems for day to day operations of more than 900 employees working at approximately 30 facilities across the USA under Consent Decree.

Hands on involvement in assessing, creating, approving and implementing process, cleaning & software validation, equipment qualification, room & facility commissioning, Training and various technical writing such as SOPs, Qualification & Validation Protocols, etc. Overall, was in charge of entire remediation activities for numerous facilities, equipment, staff and quality/compliance systems.

Managed entire Complaint Department as well all CAPA/OOS/Investigation Systems throughout numerous Technical and Quality Departments.

A&Z Pharmaceutical Hauppauge, NY 2/2009 – 3/2010

Director of Quality Assurance and Compliance

Directed entire Quality and Assurance and Compliance initiatives for domestic and international business entities. Directly interface with the drug development and manufacturing key entities such as R&D, Scale-Up, Commercial Manufacturing, Packaging, QC, etc.

Directly involved with all aspects in starting new Generic Business Unit in China.

Hosted two FDA audits during tenure at this firm. Previous FDA audit, prior to my joining the firm, lasted almost one month and yielded approximately a 40 page report of observations. Primary leader/hosted the next FDA audit which resulted in a Formal Closeout of all observations issues from the previous FDA audit, with no further issues.

The next two audits hosted during my tenure at the firm lasted a total of five days and yielded no written report/no observations.

Trained all employees involved in QA, QC, Manufacturing, Packaging, Warehousing and R&D.

In charge of hosting all regulatory audits including FDA, sFDA (Chinese FDA), EPA, OSHA, DEA, etc.

Established and/or augmented key Quality Systems (e.g. training, validation, change control, documentation, CAPA’s, etc) in order to ensure successful compliance to all applicable procedures, policies, guidelines and regulations.

Integral leader on various projects focused on augmenting the overall Quality Culture of the organizations systems and personnel.

Managed entire Complaint Department as well all CAPA/OOS/Investigation Systems throughout numerous Technical and Quality Departments.

Vendor/Supplier and Customer Audits.

Provided overall support to ensure GxP compliance within and across all operational sites.

Physical, analytical, and microbiological testing of incoming materials, in-process materials, finished products, R&D samples.

Method development.

Stability studies conducted to support product shelf life.

International Regulatory Experience.

Material Import/Export Compliance.

Inspection of incoming materials, manufacturing, and packaging lines.

Process Improvement.

Review and Submission of NDA, ANDA and OTC Regulatory Submissions.

Developed entire vendor certification program as well as implementing various standardized quality systems in areas such as Raw Materials testing, Packaging Line Yield and Efficiency Trending, Blending and Tableting Product Profiles and Characteristics, Chain of Custody, Contract Manufacturing/Packaging Quality Systems, etc.

US Nonwovens Brentwood, NY 8/2008 – 01/2009

Chief Consultant of Pharmaceutical Quality, Compliance and Technical Systems

Created entire company wide Quality Systems (e.g. SOPs, Training Program, Cleaning Validation, DI and USP Waters Systems Implementation and Validation, etc) in order to create a cGMP environment from scratch for new business operation.

Created and managed the following groups Quality Assurance and Compliance, Microbiology, Chemistry and Quality Control Labs, as well as Method and Process Development/Validation and Safety.

Managed entire Complaint Department as well all CAPA/OOS/Investigation Systems throughout numerous Technical and Quality Departments.

Completed entire set up of Quality Systems/cGMP environment and was significantly ahead of project schedule allowing firm to be audited by FDA as well as potential clients such as J&J and P&G. Thus allowed firm to manufacture products and generate revenue, six months ahead of projected timelines.

Act as subject matter expert for microbiological concerns, able to trouble shoot/provide support for issues within manufacturing areas, water systems, filling lines and manufacturing tanks

Forest Laboratories Commack, NY 8/2000 – 8/2008

Assistant Director – Pharmaceutical Operations - QA, R&D & QC (6/2006 – 8/2008)

Section Head – Pharmaceutical Operations - QA, R&D & QC (12/2004 – 6/2006)

Sr. Group Leader – Pharmaceutical Operations - QA, R&D & QC (12/2002 – 12/2004)

Group Leader – Pharmaceutical Operations - QA, R&D & QC (12/2001 – 12/2002)

Scientist III – Pharmaceutical Operations - QA, R&D & QC (8/2000 – 12/2001)

Youngest senior executive to gain four promotions in six years at Forest Laboratories Inc. growing new department from zero to twenty-three direct reports (and seven indirect reports).

Achieved a 99% employee retention rate during the course of an eight year tenure.

Managed capital and operating budget in excess 100 million dollars across multiple sites for entire Research and Development, Quality Assurance, Quality Control, Clinical and some Packaging/ Manufacturing Operations.

Excelled in reducing overall operating budget by approximately 10 million dollars over a five year period.

Served as the point person on the Global Procurement Team. Lead the team in establishing policies/procedures, form, pilot test case studies and overall analysis of trend and potential efficiencies that could result in cost reduction and overall financial compliance.

Involved in FDA and international audits including PAI and Quality Systems Audits in cGMP and cGLP environment.

Involved in reviewing and responding to FDA 483 observations and warning letters in response to regulatory inspection.

Implemented standardized quality systems from training, SOPs, qualification, validation, 21CFRPart 11, 100% inspection system for clinical materials, OOS/OOT, investigation and CAPA tracking and trending systems.

Review and Submission of NDA, IND, ANDA and OTC Drug Submissions.

Managed projects spanning from Phase I to IV for multiple products and medical devices in the overall drug development process.

Managed the entire materials import/export process for all APIs, Drug Products, Intermediates, equipment, devices, etc while dealing with FDA, USDA/APHIS, Customs. Partners, broker and other foreign regulatory.

Heavily involved in safety regulations and processes involved with agencies such as OSHA, EPA, DOT, Radiation Commission as well as MSDS for all products/chemicals.

Instrumental in participation of QA, Corporate Compliance, FDA, PAI and overall quality GMP and GLP audits as well as OSHA, EPA, Radiation Commission, and Hazardous Waste audits/inspections.

Designed and created from scratch a Universal Standardized Training System throughout, which included an evaluation process, skills lists for various positions, laboratories and functions. Additionally, created system wide policies and procedures as well as managed, conducted and overall executed numerous training programs in the areas of SOPs, compliance, audits, instrumentation, equipment, software, etc.

Developed and implemented of XRAY technology for 100% inspection of clinical trial samples.

Developed, validated and transferred key methods for new PAT technologies such as Fiber Optic Dissolutions, Fast/UPLC, Ion Mobility Spectrometry, Near-Ir and XRAY.

Concurrently, was instrumental in the development, validation, transfer and troubleshooting of staple technology methods such as HPLC, GC, Dissolution, etc.

Oversaw data acquisition systems and laboratory instrumentation in New York. This included managing the capital budget, service contracts, evaluation of technology and routine laboratory instrument qualifications, calibration, service and preventative maintenance.

Created standardized instrument and SOP management system for all applicable pharmaceutical groups/labs (e.g. QC, Analytical, BioAnalytical, Synthesis, etc.) in the organization.

PROFESSIONAL EXPERIENCE (cont.)

Created the overall design and technical specifications leading to the design of a 200,000+ Sq. Ft. Pharmaceutical Facility, that encompasses R&D, QA/QC, Clinical and Commercial Manufacturing.

Primary Team Leader in the Evaluation, Design, Construction Oversight, Building/Manufacturing Suite Commissioning, Equipment Qualification, Software/Data Acquisition System Validation (e.g. POMS Electronic Batch Record System for Commercial Product Manufacturing, Laboratory Data Acquisition Systems (e.g. Waters’ Empower, Perkin Elmers’ TotalChrom, Documentum e-doc/electronic regulatory submissions, Sparta System Trackwise for CAPA’s, etc.).

Managed various laboratories and functions from Quality Control, Stability, Method Development/Validation, Metrology, Quality Assurance, Laboratory Information Management Systems (LIMS), New Technology and Facility Acquisition, Design and Implementation.

Oread/Pfizer, Inc. Farmington, CT 12/1998 – 8/2000

Rapid Response Laboratory Scientist III/Research and Development

Managed multiple clients and pharmaceutical compounds for Contract Manufacturing Organization (Oread).

Ensured the set-up of an entire laboratory including SOPs, laboratory equipment, data acquisition systems, methods and conducted all work in accordance with standard operating procedures (SOP’s) and other applicable FDA and international regulatory guidelines.

Performed methods troubleshooting, development, validation and transfer from Pfizer to Oread.

Wrote SOP’s for equipment operation and conduct of other laboratory procedures, including validation protocols.

Searle/The NutraSweet Kelco Company Mt. Prospect, IL 12/1997– 12/1998

Analytical Chemist in Research and Development

Participated in R&D projects in support of drug development of Major Pharmaceutical Companies/Partners (both internal and external), while achieving 98% of timelines and business objectives with compliance.

Maintained direct contact with all clients while conducting various analyses pharmaceutical analyses on drug products, substances, raw materials and intermediates using HPLC Systems.

Involved in heavy usage of Data Acquisition Systems, LIMS, Spreadsheets, SOP’s, GMP’s, GLP’s, FDA, Karl Fischer, Method Validation/Development, Titrations, Formulations, Microbiology, GC and Assays.

EDUCATION

B.S. Zoology/Biology with emphasis in Chemistry, University of Wisconsin-Madison, 1994

M.S. Biology with emphasis in Chemistry, University of Illinois at Springfield, 1997

TECHNOLOGY SPECIALIZATION

Analytical Chemistry, Instrument Hardware (HPLC: Waters, Perkin Elmer, Agilent, Hitachi, Shimadzu, HPLC Detectors: RI, UV/VIS, Fluorescence, ELSD, PDA, Flow Scintillation Analyzer, Dissolution Apparatus I and II: Distek, Hanson, Varian (Apparatus I, II and III) Sotax (Apparatus IV), GC: Agilent, Perkin Elmer, LC/MS Systems: Applied BioSystems, Perkin Elmer, Waters, MicroMass, Thermo Finnagan, Fiber Optic Dissolution: Leap Technologies, Delphian, Near-IR: Foss, FT-Raman: Thermo Nicolet, Sensir, IMS: Smiths Detection, Particle Size Analyzer: Sympatec, Malvern, Thermal Analysis Instrumentation: TGA, DSC, MDSC, Characterization Technology: Imaging Systems, Microscope, Bet Analyzer, Vapor Absorption, DCA, FTIR, Polarimeter, Automated and manual KF, Robotic Systems: NOVI Ictus, Zymark TPW and Multidose, Beckman and Perkin Elmer Liquid Handling Systems and Software Qualification/Validation: Perkin Elmer Turbochrom 6.1.1, TotalChrom 6.2, Waters Millennium, NuGenesis, Labware LIMS, Electronic notebook, Blue Mountain Calibration Manager. FogBugz,Watson, Documentum, Labtronics Nexxis, Labware, Analyst 1.2, 1.3, 1.4, Mass Lynx, ChemStation, Calibration Manager, Documentum, OPTDISS, Fiscal and Capital Budgets, Designing of R&D Laboratories/ Buildings, Audits, Compliance, SOPs, Acquisition, Development & Implementation of New Technologies and Methods.

PROFESSIONAL AFFILIATIONS

Member of American Association of Pharmaceutical Sciences (AAPS), Member of American Chemical Society (ACS). Member of Institute of Validation Technology (IVT), Council Member of Town Audit Committee, Council Member of Town Legislative Committee

LANGUAGES

Speak all four languages fluently and can also read and write Spanish.

English

Spanish

Hindi (Indian Language)

Punjabi (Indian Language).

PROFESSIONAL PRESENTATIONS AND PUBLICATIONS

Numerous Publications and Presentations to the Pharmaceutical Sector, available upon request.

Contact this candidate