Project Management Engineering

NILESHKUMAR PATEL

** ****** ******, ******, **

C: 732-***-****, H: 732-***-****

**********@*****.***

Objective:

To secure a Chemist position in a regulated GLP/cGMP environment.

Experience:

Jan 2005 – Nov 2016

Colgate Palmolive, Co., Morristown, N. J. Analytical Chemist

Conduct analysis on Stability samples, Raw Materials, In-Process Samples and Finished Products in accordance with established methods, specifications and protocols.

Ensure GLP/cGMP Analytical Laboratory meets all FDA, OSHA & EPA requirements.

Experienced in routine testing of Active Pharmaceutical Ingredients (API’s), Wet Chemistry, Organoleptic Testing, Preparations of Mobile Phases, Buffer Solutions, Indicators and TS Solutions.

Perform analysis using analytical methods involving analytical instrumentation including HPLC, GC, FTIR, NIR, UV-Vis, pH Meters, Viscometers, Conductivity Meters, Specific Gravity Apparatus’s, Karl Fischer titrations (KF) and Auto Titrators.

Actively participate and assist during FDA Inspection and Internal Audits.

Document & review laboratory work using laboratory notebooks in compliance with GLP / cGMP requirements.

Proficient in writing Laboratory Investigation Reports (LIR’s), Standard Operating Procedures (SOP’s) and Standard Practical Instructions (SPi’s)

Sound understanding and well experienced in USP-NF to provide concrete knowledge.

Provide support to Engineering during Scale-up process, Engineering Manufacturing Operation’s (EMO’s), Failure Investigations, Non-Conformances and Corrective Actions Preventative Actions (CAPA’s)

Coordinate with Planning & Production team to test and release product on time.

Contact Vendor or Research & Development to resolve COA or PDM related issues.

Provide assistance with Technology Transfer of new instrumentation and methodologies.

Act as Primary contact for IQ, OQ, PQ, Preventative Maintenance and Time Interval Calibration of all Analytical Instruments: HPLC, FTIR, Uv-Vis, Viscometer, CEM Oven, Balances.

Actively provide Finished Product Release’s on daily basis to Documentation group.

Troubleshoot and Service instrumentation in accordance with approved Method, Procedures or Protocols.

Prepare final project report & Communicates results according to project timelines.

Adamantly provide Training for Methodology, Instrumentation and Documentation to all analysts Permanent and Temporary.

Maintain organoleptic standards for Raw Materials, In-process and Finished Products.

Current Project Management Responsibilities:

Cleaning Validation of Manufacturing Equipment

Ordering of all Equipment Supplies

Annual Product Review(APR)

Laboratory Equipment Experience

HPLC, FT-IR, Uv-Vis spectrophotometer, GC, Autotitrator (Tiamo), NIR (RLA & Opt probe), pH Meters, Viscometers, Conductivity Meters, Karl Fischer titrations (KF), LOD, Dissolution

Skills:

Experience in chemistry lab procedures, USP methods and pilot-plant.

Proficient with Excel, Word, Power Point, SAP, Totalchrom.

Skilled in technical writing, public speaking, presentations.

Education:

M. S. Pharmaceutical Engineering, May 2012, NJIT, NJ

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