Engineer Quality Control

SUMMARY OF CAPABILITIES:

• Knowledge of Code of Federal Regulation including 21 CFR Part 11, 210, 211, 312, 820.

• A good understanding of GMP, GCP and GLP as related to the FDA regulations, ISO 9001 and EMEA regulations.

• Proficient in developing Fish Bone diagram, Process/Value stream Mapping.

• Proficient in use of Microsoft Office (Word, Excel, Power Point, Outlook).

• Capable of developing Standard Operating Procedures (SOPs) and equipment specifications.

• A good understanding of GXP as related to the FDA regulations, ISO 9001 and EMEA regulations.

• Excellent oral and written communication, analytical and interpersonal skills.

• Capable of working both independently and in a team-oriented working environment and ability to manage multiple priorities in a fast-paced environment.

• Capable of performing cGMP risk assessment, Root Cause analysis and recommending CAPA.

• Expert knowledge of Quantitative/Qualitative determination of raw materials (APIs and excipients) by use of Chromatography, IR spectrometry, UV spectrometry, pH Metry, Titrimetry and other compendial methods.

• Good understanding of new test method development, method validation and verification.

• Scientific knowledge of formulations, physico-chemical and biopharmaceutical principals underlying pharmaceutical dosage forms.

• Experience in working with analytical test equipment and wet chemistry methods.

EDUCATION:

Masters of Science in Pharmaceutical Manufacturing (GPA: 3.83)

Graduate Certificate in Validation and Regulatory Affairs (GPA: 3.83)

Stevens Institute of Technology, Hoboken, NJ (May 2010)

Course work in GMPs in Pharmaceutical Facility Design, Bioprocess Technology in Pharmaceutical Manufacturing, Validation & Regulatory Affairs, Quality in Pharmaceutical Manufacturing, Contemporary Concepts in Validation, Regulation & Compliance in the Pharmaceutical Industry, Design of bioprocess equipment and piping, FDA cGMP guidelines, FDA's Approach to GMP Inspections of Pharmaceutical Companies, Packaging line design, acquisition, commissioning and qualification, post-marketing pharmacovigilance and complaint handling.

• Presentation, “21 CFR 58 - Good Laboratory Practice Regulations”, “ICH Q9: Quality risk Management Methodology”

• Paper, “Implementation of Green concept in field of Pharmaceutical Manufacturing”, “FDA Quality Trend in 21st Century”.

• Research Project on “Preparation of Eggless Cookie as per FDA cGMP requirements”(My role: QA Engineer)

Bachelors of Pharmacy (GPA: 3.5)

Anand Pharmacy College, Sardar Patel University, Gujarat, India (May 2008)

Course work in Pharmaceutical Chemistry (Inorganic, Organic and physical), Pharmaceutical Engineering, Pharmaceutical Analysis, Pharmacology, Pharmaceutical Microbiology & Biotechnology, Medicinal Chemistry, Industrial Pharmaceutics, Dosage form Design Bio-Pharmaceuticals & Pharmacokinetics, Clinical Pharmacy.

PHARMACEUTICAL EXPERIENCE:

Neutrogena Cosmetics,

Johnson & Johnson Group of Consumer Companies, Los Angeles, CA Nov 2010 - Current

Scientist-I,

Job Responsibilities:

Supports Product development department for release and qualification of new and/or existing raw materials (Actives and excipients) to support new/ modified formulas.

Provides analytical and technical support to product development and Technical assurance groups for raw material related issues.

Performs analytical testing and release of raw materials (Actives and Excipients) as per in-house, USP and EP Test methods in a timely manner to support R&D GMP/ Pilot batch.

Develops and revises Certificate of Analysis and Raw material specifications for new/ existing raw materials.

Performs analytical qualification of new chemical raw materials and suppliers.

Tests, documents and reports for stability testing of laboratory and pilot scale batches.

Provides analytical and technical support for purified water system.

Supports qualification activities for analytical laboratory instruments.

Relax Pharmaceuticals, Vadodara, Gujarat, India Apr 2008 - Sep 2008

Quality Control Scientist

Job Responsibilities:

Analytical and physical testing of raw materials, in-process and finished products.

Investigation of analytical test data for OOS results.

Maintenance and review of laboratory data for compliance.

Preparation of SOPs, validation documentation, qualification protocols for analytical instruments.

Development, validation and verification of new analytical test procedures.

Review and analyze batch record for reagent preparation, intermediates and analytical test results.

Marsha Pharma Pvt. Ltd., Vadodara, Gujarat, India Apr 2007- Sep 2007

QC Analyst

Job Responsibilities:

Performed QC/QA Testing of raw materials and finished products to determine quality and integrity of materials, product stability study.

Performed assay testing for APIs and preservatives by Titrimetric, UV/ Vis Spectroscopy and chromatography as per IP/ USP monograph.

Supports testing for Physical and chemical property of raw material.

Executed TOC analysis for CIP and COP effectiveness for cleaning validation.

REFERENCES:

References are available upon request.

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