Resume Vishal Shah
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Vishal Shah [email protected] 64, Jill Ct Cell: (908) 672 2896 Monmouth Jct, NJ 08852 ------------------------------------------------------------------------------------- -------------------------------------------------------------------- OBJECTIVE Develop, enhance & monitor sustained quality practices in-line with global compliance and Global Regulatory standards. CAREER SUMMARY Over 23 years of work experience in various disciplines of API manufacturing in Pharma industries. Presently employed with one of the leading, Global API and Pharmaceutical multi dosage form manufacturer. Developing and enhancing Quality Assurance standards at corporate level. Vendor developments and conducting Vendor audits – Supply chain management Facing regulatory and conducting cGMP audits. Training & cGMP guidance Developing manufacturing sites as per ICH requirements in order to meet USFDA & EU expectation. Regulatory impact and risk assessment of the proposed changes & getting regulatory approvals On continuous basis identifying the changes in the regulatory requirements & performing the gap analysis to enhance Quality system. Technology transfer & Scale-up. Impact & risk assessment in line with ICH Q9 & Q11 Successfully handled 8 API locations on quality fronts being in Corporate Quality. Well versed with GAMP5 guidelines and implemented them in plants. PROFESSIONAL EXPERIENCE – AT MANUFACTURING LOCATION SUN PHARMACEUTICALS INDUSTRIES INC. AT CRANBURY, NJ USA August 18, 2014 – Present Manager – QA
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Transcript of Resume Vishal Shah
Vishal [email protected]
64, Jill Ct Cell: (908) 672 2896 Monmouth Jct, NJ 08852 ---------------------------------------------------------------------------------------------------------------------------------------------------------OBJECTIVE
Develop, enhance & monitor sustained quality practices in-line with global compliance and Global Regulatory standards.
CAREER SUMMARY
Over 23 years of work experience in various disciplines of API manufacturing in Pharma industries. Presently employed with one of the leading, Global API and Pharmaceutical multi dosage form manufacturer. Developing and enhancing Quality Assurance standards at corporate level.
Vendor developments and conducting Vendor audits – Supply chain management
Facing regulatory and conducting cGMP audits.
Training & cGMP guidance
Developing manufacturing sites as per ICH requirements in order to meet USFDA & EU
expectation.
Regulatory impact and risk assessment of the proposed changes & getting regulatory approvals
On continuous basis identifying the changes in the regulatory requirements & performing the gap
analysis to enhance Quality system.
Technology transfer & Scale-up.
Impact & risk assessment in line with ICH Q9 & Q11
Successfully handled 8 API locations on quality fronts being in Corporate Quality.
Well versed with GAMP5 guidelines and implemented them in plants.
PROFESSIONAL EXPERIENCE – AT MANUFACTURING LOCATIONSUN PHARMACEUTICALS INDUSTRIES INC. AT CRANBURY, NJ USA August 18, 2014 – Present
Manager – QA
Responsible for the Vendor Qualification (CMO, Contract labs, API, Excipient and packaging component manufacturer)
o Responsible for audits: Internal & External.o Vendor Evaluation, Audit and approval.o Quality Agreement.o Due diligence
PROFESSIONAL EXPERIENCE – AT CORPORATE QUALITY
SUN PHARMACEUTICALS INDUSTRIES LIMITED November 2007 – July 15, 2014Senior Manager – Corporate Quality
Corporate QA Functions / Inter-phase with locations
Quality system introduction / updating through guideline / directive & global CAPA.
Vishal [email protected]
Page 2-----------------------------------------------------------------------------------------------------------------------------------------------
o Identification of guideline/ directive topics from GMP trends, Regulatory audits, internal
audits, incidence investigations, new regulatory guidelines, demand from plants.
o Evaluating the changes with respect to US & EU Regulatory requirements in line with
guidelines on changes to approved NDA / ANDA.
Market complaint Handlingo Registration, evaluating adequacy of investigation and action plan for prevention.
o Trending and assessment of complaint and measuring effectiveness of Corrective and
Preventive Action.
Training and development o Training need identification for subordinates and site quality function.
o Evaluation of trainers.
o Preparation of training manual.
Co-ordination for external audit which includes foreign consultant / customer / regulatory agencies
Corporate Quality auditso Auditing of system, facility, documentation as per the schedule.
o Extrapolation of observation of one plant to other plants to ensure global compliance.
o Reporting of critical / major CQ Audit observation to management (QRB)
Validation and Qualificationso Guideline to plants for company’s policy/ strategy on validation/ qualification.
o Instrumental in implementation of Continued Process Verification across the globe
according to current USFDA and EU expectations on Process Validation.
Operations Managemento DMF submission planning, identifying gaps in the process, queries handling.
o Suggesting the innovative ways to improve operational efficiency of the different
departments of different manufacturing locations of the organization.
Project Management o Green field projects monitoring Quality point of view from the commissioning to
commercialization and new technology across the globe and monitoring for smooth
implementation.
o Introduction of Monitoring of DMF projects from R&D to manufacturing location. It includes
implementation of QBD principles (ICH Q11, ICH Q9 etc.)
Process Improvement
Vishal [email protected]
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o Control on Process changes and Regulatory filings.
o Keeping a track on the process changes.
Materials Management and Supply Chain Managemento Implementation and monitoring of supply chain management systems.
o Vendor evaluation and periodic on site audit of different API manufacturers.
Information Technology (IT)o Heading Quality-IT group and instrumental in software validation and implementation of
various software across the globe e.g. Quality Management System, Statistical Analysis
Tool, Enterprise Resource Planning, Laboratory Information Management System,
Document Management System, Chromatography Data Systems etc.
PROFESSIONAL EXPERIENCE – AT MANUFACTURING SITES (Quality Assurance) Dec 1996 – Nov 2007
Sr. No. Company name Designation Period
From To1. Lupin Limited , Bhopal, Madhya
Pradesh, India.Manager – Quality Assurance
Aug 2006 Nov’ 2007
2. Alembic limited, Baroda, Gujarat, India. Assistant manager – Site Quality Assurance
Oct 2002 Aug 2006
3. GlaxoSmithKline Pharmaceuticals Ltd Ankleshwar, Gujarat, India.
Executive - Quality Assurance
Dec’ 1996 Oct’ 2002
Heading Quality Assurance department
Executed day to day activities of Quality Assurance Department to ensure that the Departmental
activities are carried out smoothly.
Maintained Group’s Quality Standards to fulfill the requirement of marketing & Regulatory firms.
Handled & maintained following Site functions / documentations: -
o Preparation & implementation of the systems and procedures (system & Departmental
SOPs) for the site.
o Approving Deviation and change controls.
o Market Complaint handling & investigation of complaint.
o Re-processing & Rework.
o Handling of return goods.
o Vendor evaluation, development & approval
Vishal [email protected]
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PROFESSIONAL EXPERIENCE – AT MANUFACTURING SITES (PRODUCTION) July 1991 – Dec 1996
4. Cipla Laboratories Ltd, Patalganga, Maharashtra, India.
Technical Officer - Manufacturing
Mar’1994 Dec’1996
5. Cadila Laboratories Ltd. Ankleshwar, Gujarat, India.
Technical Supervisor – Manufacturing.
July’1991 Mar’1994
Execution of shop floor activities: o Ensuring no adverse Material Usage Variance (MUV) at any stage of the product.
o Ensuring product / batch manufacturing and deliveries in time as per customer’s
requirement.
o Training to all plant personnel involved in critical/non-critical operations (Safety & GMP).
o Preparation of package for On The Job Training (OJT), Class room training assessment
and record for each personnel.
Documentation:o All the records/ documents pertaining to Production and Quality are maintained and
updated time to time.
o To prepare planner for cleaning schedules and ensure compliance.
o Acting as a host during internal GMP & Safety Audits. For external audits acts as an
expert.
o To ensure proper documentation for change control procedures, product failure
investigation and regulatory compliance.
Process Validation:o To participate as a Validation working party member to Validate manufacturing process
and utilities and its review.
EDUCATION Master of Science in Chemistry from Madurai Kamraj University, Madurai, Tamilnadu, India.
Bachelor of Science in Chemistry from South Gujarat University, Bharuch, Gujarat, India.
Post Graduate Diploma in Business Management from Gujarat University, Ankleshwar, Gujarat,
India.
PROFESSIONAL RECOGNITION
Lead Auditor – ISO certified for conducting GMP Audits.
Vishal [email protected]
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PERSONAL
Lawful Permanent Resident of US (Green Card holder); Married, 2 children
