Quality Assurance Control

PARIN B PANDYA

** ******* ******, *** 3-201-***-****

Jersey city, New Jersey 07306 ***************@*****.***

OBJECTIVE: To work in company where I can use my knowledge and practical experience for better

effectiveness and growth of company.

EDUCATION: MS in Pharmaceutical Manufacturing Engineering December 2013

Stevens Institute of Technology, Hoboken, NJ GPA 3.2

Bachelors in Pharmacy August 2011

KB Raval College of Pharmacy, Gujarat, India GPA 3.0

CERTIFICATE: Pharmaceutical Manufacturing Practices, Validation and Regulatory Affairs, Certificate of

appreciation by “Women in Pharma club” by Stevens Institute of technology, GMP training

certificate

COURSEWORK: Validation and Regulatory Affairs, Project Management, Regulations, Compliance and Quality

in Pharmaceutical Industry, Manufacturing and packaging Of Solid, Liquid & Semi Solid

Dosage forms, Lean Six Sigma, Contemporary Concepts in Validation

EXPERIENCE: Claris Pharmaceuticals, India May 2010 to July 2010 and April 2011 to May 2011

Quality Assurance, Production & Analytical Development Laboratory Functions

Preparation of test solutions, volumetric solutions and reagents

Perform qualitative & quantitative analysis to confirm specifications

Stevens Institute of Technology Jan 2013 to May 2013

QC manager and Validation Associate

Preparation of Validation Master Plan and IQ, OQ & protocols

Use of metronome to observe weight control filling process

Validation & Calibration of all Laboratory equipments, Process Capability

Performed oven temperature distribution study and sampling technique

SKILLS: Extensive knowledge of FDA, GMP, OSHA, GCP, GLP, 21CFR part 11,110,210,211 & 820

Regulations

Participation in GMP audit

CGMP laboratory notebook documentation

Revision & Maintenance of SOP, batch records, protocols & other documentation system

Approach to FMEA, CAPA, QSR, QbD, PAT, Lean six sigma, Root cause analysis & ICH

Q8, Q9& Q10, ISO 9000, 9001, 9002, 9003, 14000.

Worked on modern instruments like HPLC, GC, UV, TLC & TOC analyzer

Extensive knowledge of IQ, OQ & PQ, Cleaning Validation and Swab Sampling

Gage R&R, Linearity & Bias study, process capability

Medical Device Reporting & Adverse Event Reporting

Handling of raw materials and Laboratory equipments & Formulation stability which include

physical measurement and analytical test methodology

Wide exposure to Quality Control, Quality Assurance, Manufacturing, Validation Compliance

and Regulatory areas

COMPUTER: MS office, Minitab 16, M-Files document management system, troubleshoot.

SKILLS

MOTIVATION: Strong aptitude, Multitasking, Good communication, Aware of Team Dynamics & Conflict

Modes (Thomas Kilman), Leadership

REFERENCES: Available upon request

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