Gaurav Patel

Phone No: 912-***-****

email Id: xufvbl@r.postjobfree.com

OBJECTIVE

To secure position in the field of Pharmaceutical that allows utilizing my knowledge and experience to contribute towards organization’s growth and objective.

QUALIFICATION SUMMARY

• Ability to implement validation approaches in Pharmaceutical Manufacturing environment in compliance with FDA which include risk assessment and statistics in validation, commissioning and qualification, Cleaning Validation, Equipment Qualification vs. CVS, lean manufacturing, six sigma and PAT initiative.

• Detail knowledge of Quality Programs and tools with specific application to the particular requirements of Pharmaceutical Industry.

• Expert of Regulation in general, focusing on US FDA and EU. And also of execution of regulatory strategy and ethical issues in medical research and production.

• Knowledge of cGMP compliance issues in designing of Pharmaceutical facility, and Design and Management of Aseptic Pharmaceutical Manufacturing facility.

• Manufacturing and Packaging of Pharmaceutical Oral Solid Dosage Products.

EDUCATION QUALIFICATION

• Master of Science in Pharmaceutical Manufacturing (GPA: 3.46) Jan 2010 – Dec 2011

Stevens Institute of Technology, Hoboken, NJ

• Bachelor in Pharmacy, Dayananda Sagar Institute, Bangalore, India Aug 2004 – Oct 2008

• Certificate Program in Validation and Regulatory Affairs.

RELEVANT COURSES

Introduction to Pharmaceutical Manufacturing, Validation and Regulatory Affairs in Pharmaceutical Manufacturing, Contemporary Concepts in Validation, Quality in Pharmaceutical Manufacturing, Regulation and Compliance in the Pharmaceutical Industry, Good Manufacturing Practice in Pharmaceutical Facilities Design, Design and Management of Aseptic Pharmaceutical Manufacturing processes, Pharmaceutical Finishing and Packaging of Oral Solid Dose, Introduction to Project Management, Engineering Economics and Cost Analysis.

EXPERIENCE

Stan-Rel Pvt. Ltd. (Production Supervisor), Vadodara, India. Jan 2009 – Nov 2009

• Worked as Production Supervisor in Compression and Coating Department.

• Experience of working in cGMP environment.

• Responsible for Production planning and generating Bill of Material for dispense of raw material from RMS department.

• Performed various manufacturing support activities like line clearance of the room, troubleshooting with the equipment, In-process testing of tablet.

• Experienced in handling documentation system, change control system, validation, investigation of out of specification procedure and report, and also of self-inspection and quality audit report.

• Also performed annual product review and handling of customer complaints.

Kaptab Pharmaceutical, (Intern), Vadodara, India. Mar 2008 – Apr 2008

• Gained insight Knowledge of various department of Pharmaceutical Industry, focusing on assurance of quality and production of drugs.

• Assisted Manager and QA personnel in their duties.

TECHNICAL SKILLS

• Validation: Process Validation, Cleaning Validation, Equipment Qualification (IQ, OQ, PQ) and Commissioning.

• Quality tools: Quality by design, Risk management and assessment, CAPA, Change Control, Root Cause analysis tools, Control chart, Lean, Six Sigma, Pharmacovigilance.

• Lab Skills: Spectroscopy, Chromatography, Disintegration, Dissolution, Assay, and TOC analysis.

• MS Windows (2000, XP, Vista, 7), Mac OS X, MS Office Suite (Word, PowerPoint, Access, Excel, Outlook), MS Project, MS Visio.

• Statistical Software – Minitab 15

ACADEMIC PROJECTS

HDB Project (Project Manager).

• Preparation of Eggless Cookies, by the same way we manufacture drug.

• Preparation of Project Charter and Project Plan.

• Facilitated and managed weekly meeting sessions with team members to review project requirements. And implemented FDA guidelines to avoid non-compliance and delay in production.

• Performed various experiment for the process development like DOE of content uniformity and also of cleaning process by performing Total Organic Carbon analysis of mixer bowl using Seiver’s 900 Portable TOC Analyzer.

• Assisted in preparing and reviewing SOPs, IQ, OQ and PQ of mixer and oven. Participated in preparation and execution of Process validation protocol and Cleaning Validation Protocol.

FAT Protocol for Depyrogenation Tunnel.

• Develop FAT Protocol for Depyrogenation Tunnel used to sterilize glass containers, based on the provided URS for that system.

US ANDA (Abbreviated New Drug Application).

• Submission Document and purpose of this submission.

• Content Requirements to be included in the submission.

• Strategies for submission approval like meeting with the agency involved, inspections etc. and the process of approval.

• Overview of associated costs and timeline from submission to approval.

Genzyme Consent Decree.

• Reason and regulatory enforcement background leading to consent degree.

• Type of Quality Management System would recommend, implementing to begin to turn the consent decree situation.

Facility Design for Soft Gelatin Capsule.

• Design of Facility based on flow of Person, equipment and material.

• Equipment needed for the Preparation of Soft Gel and Packaging Equipment.

Quality Trends in FDA Warning Letters on Pharmaceutical GMP.

Sarbanes-Oxley regulation.

REFERENCE

Available upon request.

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