Jayni Maulendra Shah

****, ******** ****, **** *********, NY 12061

Email:- acqht3@r.postjobfree.com

Cell:- 630-***-****

OBJECTIVE:

To obtain a position as a multi-disciplined Validation engineer or in a related field with varying responsibilities in a pharmaceutical manufacturing organization.

TECHNICAL EXPIRIENCE:

1) Validation Project (Stevens institute of technology) Aug-Dec 2014

Development, approval and execution of Validation protocols. (IQ, OQ, PQ)

Drafted User Requirements and Design Qualification templates for GMP critical systems.

Performed Project considering Six Sigma, PAT, Qbd, and Validation Risk assessment in order to increase product quality and reduce validation efforts.

Developed FMEA, Fishbone and Process Flow diagram for design, process and Equipment.

Participated in review/approval process of Functional Requirement

Specification and Detailed Design for “GMP Critical Equipment”.

Responsible for Execution of (SAT) of GMP systems and equipment.

Performed Validation activities by swab sampling using design of experiment, Process development and control, process capability, Statistical development like Gage R&R and ANOVA using Minitab 15.

Performed Cleaning Validation activities by swab sampling using TOC analyzer.

Responsible for Preparation of various batch Manufacturing Record and protocols as per CGMP.

Co-ordinate and performed internal and external audit to ensure compliance with GMP.

Responsible for weekly project status updates to senior management focus on milestone accomplishments, challenges and status of project schedules.

2) West Coast Pharmaceutical LTD, Gujarat India. May- June 2012

Intern:

Quality control and Manufacturing Department

Supervised manufacturing of tablet capsule and parenteral

Performed Quality control test

Conducted Failure analysis of defective product.

Maintained quality standard for material and product

3) Sunij Pharmaceutical LTD, Gujarat India. April-July 2013

Quality Control Analyst:

Work with member of Manufacturing, QA, RA, and RD

Ensure compliance with CGMP and SOP

Participate in required training Activities

EDUCATION:

Stevens Institute of Technology, Hoboken, New Jersey May 2015

Master of Science in Pharmaceutical Manufacturing Engineering

RELEVANT COURSEWORK:

Introduction to pharmaceutical manufacturing engineering

Validation and Regulatory affairs in pharmaceutical manufacturing Engineering

Economics and cost Analysis

Manufacturing and packaging of Pharmaceutical oral solid dosage

Products Good manufacturing practice in pharmacy

Bioprocess Technology in API manufacturing

Quality in pharmaceutical Manufacturing

Project management fundamentals

Contemporary concepts in pharmaceutical Validation

Regulation and Compliance in pharmaceutical Industry

SKILLS:

Lab Skills: Preparation of wet granulation and formulation of different dosage form, HPLC, cleaning Validation, Titration, chromatography, Quality test for pharmaceutical dosage form, analysis of different compound with spectroscopy, swab sampling.

Software Skills: MS word, MS PowerPoint, MS excel, Minitab, M-files (E document management System)

Process skills: Gage R&R, Process development, FMEA, development of SOP, calibration of equipment.

ACHIEVEMENTS:

Participated in 61st Indian Pharmaceutical Congress, Nirma University 2009

Participated in Personality Development Program conducted by globarena (Hyderabad) and H M Patel Career Development Centre, Gujarat, India. June 2010

Certified in Environment and Disaster Management exam June 2011

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