Quality Assurance Manufacturing

SUCHITKUMAR SHAH

*** *.*. ******* *** 732-***-****

Branchville, NJ 07826 *********@*****.***

OBJECTIVE: Seeking a challenging carrier in Quality Assurance & Compliance Associate in Pharmaceutical

Industry.

EDUCATION: Stevens Institute Of Technology, Hoboken, New Jersey GPA: 3.53

Master of Science in Pharmaceutical Manufacturing JAN 2009 - Dec 2010

MAJOR SUBJECTS: Introduction to Pharmaceutical Manufacturing & Project Management,

Validation & Regulation Affairs in Pharmaceutical Manufacturing, Bioprocess Technology in

Pharmaceutical Manufacturing, Pharmaceutical Facility Design, Regulation & compliance in

Pharmaceutical Industry, Design & Management of Aseptic Pharmaceutical Manufacturing Process.

CERTIFICATION: Pharmaceutical Manufacturing Practices

Bio-process Systems Pharmaceutical Manufacturing

cGMP Documentation & Good Documentation Practices

Gujarat University, Ahmadabad, India GPA: 3.79

Bachelor of Science in Pharmacy AUG 2004 - May 2008

SKILLS: Laboratory: Quality testing for tablet, Capsule & Parental, Dissolution & Disintegration Apparatus,

Pharmacological & Microbiological Testing, Chromatography, Cleaning Validation

Software: Microsoft Office, Microsoft Project

Operating System: Windows Vista, Windows XP, Windows 7

PROJECTS: Quality by Design & Process Analytical Technology for Quality Improvement

• Studied ICH Q8,Q9 and Q10 guidance along with FDAs guidance

• Analyzed A-Mab case study by CMC biotech working group for QBD implementation in

Biopharmaceutical manufacturing

Warning Letter Analysis of Pharmaceutical Industry

• Analyzed 30 warning letters and Current Good manufacturing Practices

• Identified pattern of inspection and area of focus based on most frequently violated sections

• Studied lean, Sigma and Total quality Management to improve compliance issues

Facility Making for Biopharmaceuticals

• Studied different area & location For Bio-Pharmaceutical

• Analyzed different Area codes specially for North Carolina

• Finally manipulate sketch for Biopharm Facility Design as per the given project.

Other Minor Projects & Presentation:

• Facility for making USP water for injection

• Facility layout for Hard Gelatin Capsules, Layout for Bottle & Blister Packaging Line.

• Patient compliance & personalized medication & cGMP issues in clinical studies.

• Bioavailability & Bioequivalence Project.

• Poster presentation at NJIT on the topic of DNA Manipulation in Nano-Technology, April 2009

• Design Aseptic plant and facility development according to cGMP and EMEA consideration

• 2nd prize in Poster presentation on “Different System of Medicine” for National Pharmacy Week, Dec 2007

EXPERIENCE: Nutra-Med Packaging Inc., Rockaway, New Jersey

Quality Assurance Inspector Feb 2011 to Oct 2011

• Review packaging records for completeness and accuracy to ensure compliance.

• Inspect for and promote cGMP compliance in packaging and record keeping operations.

• Prepare and execute validation protocols, including IQ, OQ, PQ for packaging equipment.

• Maintain quality documents, reports, and records, such as batch records, quality agreements, training records, destruction reports, SOPs, specification files, change controls, etc.

• Oversee environmental monitoring program.

• Oversee calibration program, including daily scale calibrations, monitoring of monthly calibration charts, and working with third party to calibrate and certify appropriate devices and equipment.

• Monitor the packaging and labeling processes to help identify and present to management

ongoing initiatives for continuous improvements to the organization's quality systems.

• Handled successfully FDA, DEA, Customer and other audits

• Conduct audits of company's suppliers as necessary

• Conduct Internal Audit to keep up the facility compliance to GMP's & Inspected & promoted cGMP compliance in Packaging Operation

• Approved & released packaging room for production

• Sampling & Inspection of all in-process & finished product testing which include vacuum test,

weight & count Verification. Visual inspection for lot & expiry codes as well as use of correct

Product & Prepared product reconciliation & Packaging components, container & shipper labeling

• Packaging Validation, Perform IQ, OQ, PQ for Packaging equipment

• Reviewed packaging records for completeness & accuracy to ensure compliance with SOP

• Document Control: Set up & maintain Quality Documents such as batch records, Quality

agreements & Destruction report.

Alembic Research Center, Vadodara, India

Research Associate Jan 2008 to Sep 2008

• Working with various the analytical method for synthesized drug & doing procedures for testing chemical assays

• Pre-formulation studies: log D, pKa, equilibrium solubility, pH and thermal solution stability.

• Develop stability indicating HPLC methods to study drug purity on Waters and Agilent HPLC systems

• Writing technical reports and milestone reports such as clinical lead selection

Moxy Laboratories, Vadodara, India

Curriculum Practical Training May 2007 to Aug 2007

• Worked in Tablet, Capsule and Powder Manufacturing Process

• Prepared Batch Manufacturing Records

• Operating Tray Dryer & USP/IP tablet dissolution apparatus

• Manufacturing Evaluation of Tablet, Capsule, Suspension, Emulsion, Cream & Syrup

• Learned QA/QC lab and outsourcing business marketing

MEMBERSHIP: International Society of Pharmaceutical Engineering

Gujarat State Pharmacy Council-Registered Pharmacist

REFERENCES : Available upon request

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