Quality Control Assurance
Resume:
****, * * ******* ****, Apt#* Ankit Mehta
*******@*****.***
Jersey city NJ-07306-6802
OBJECTIVE: To perform in proficient environment with emerging
organization.
EDUCATION: Stevens Institute of Technology, Hoboken, NJ
M.S. Pharmaceutical Manufacturing Engineering,
(Dec 2009)
Related Course: Bio-technology in API manufacturing, Validation
and Regulatory Affairs in Pharmaceuticals, cGMP in
Pharmaceutical Facilities Design, Pharmaceutical Finishing and
Packaging, Engineering Economics and Cost Analysis, PAT in
Pharmaceutical Operations, Introduction to Project Management,
Quality in Pharmaceutical Manufacturing, Contemporary Concepts
of Validation, regulations and compliance.
Rajiv Gandhi University of Health Sciences, Belgaum, India
B. Pharm. (May 2007)
Academic Projects: Manufacturing process and formulation of Capsule Shell
and tablets (May 2008)
Assigned as Project Engineer preparing IQ, OQ protocols and
SOP's for the machines used during manufacturing of the
pharmaceutical product. (Jan 2009-Dec 2009)
Swab sampling using TOC count Unit for Cleaning Validation
(CIP). ( Jan 2009-Dec 2009)
WORK
EXPERIENCE: Vifor India Pvt Ltd Pharmaceutical Company, Gandhidham, Gujarat
India (Jan 2006-Jan 2008)
. Received training in Pharmaceutical Production, Quality
Control, Quality Assurance
. Performed various quality control tests including raw
material classification, in-process and finished product
quality control tests and documented procedures and
standard techniques involved in tests.
. Responsible for writing, reviewing and approving Validation
Master Plans, User Requirements Specs, Functional
Requirements Specs, and IQ/OQ/PQ protocols. Coordinate
validation activities for multiple validation projects
and perform CSV Risk assessments
. Worked on CIP cleaning validation systems. Writing
protocols for cleaning studies using swab sampling
technique. Also executing protocols and preparing summary
reports
. Worked with R & D scientists to perform formulations of
tablets and capsules, suspensions, pre formulation studies,
immediate release and extended release formulations,
different types of coatings
. Performed the routine analytical tests using HPLC, GC, TLC,
IR, Dissolution, Bioassay, ELISA, Protein purification,
Auto Dissolution, pH Meter, UV-Vis Spectrophotometer,
Polari meter under FDA regulatory environment
SKILLS:
. Knowledge of the 21 CFR 11 for Electronic Record and 21 CFR
210/211 for the Good Manufacturing Process for finished
dosage form along with ICH Guidelines and QSR Regulations.
. Thorough working knowledge of quality systems methods and
practices(DOE, FMEA, Control plans, Lean Manufacturing
Concept, DMAIC, FTA, Root Cause Analysis, CAPA, etc).
. Lab Skills: Performed regular Quality Control tests on
Pharmaceutical products, Various Formulations for
Tablet(Wet Granulation),Capsule and Sterile formulations,
Rollar Compaction,validation of the machines used during
the operation, Cleaning validation(CIP/SIP). Performed
HPLC/TLC, GC,IR methodology to detect compounds present in
samples and assay it. Swab sampling by using TOC count
unit for cleaning validation.
. Computer: Microsoft Excel, Word, Power Point, Minitab 15,
Spreadsheets, MS project
. Languages: Fluent in English, Hindi and Gujarati
. People Skills: Team player, experience in both group and
individual presentations and projects. Extensive travel
allowed exposure to a wide variety of cultures and people.
Broadened technical skill set through on the job training
including problem solving abilities. Improved on
organizational, communication and networking skills by
performing well in the corporate world.
AREA OF
INTREST: Quality Control in pharmaceuticals, Pharmaceutical
Validation Engineering, Analytical Chemist
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