Resume

Sign in

Quality Control Data

Location:
Illinois, United States
Posted:
October 19, 2016

Contact this candidate

Resume:

Anil K. Patel

**** ***** **** **.

Wilson, NC-***93

Ph: (C) 973-***-**** E-mail: acw5bf@r.postjobfree.com

Objective:

Looking forward to a challenging position that utilize my education, skills and experience of Pharmaceutical field. Providing valuable contribution to the organization with personal as well as organizational growth.

Profile:

Proven Quality control/QA experience including, Knowledge of GMP’s, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance. Working knowledge of validation principles, pharmaceutical processes, quality systems and FDA regulations..

Self starter, ability to adapt in various departments of quality system.

Skills:

Instrument expertise:

Aanalytical balances, HPLC,UPLC,GC.ICP,IR,FT-IR, Titrate (DS716 and DS702), UV-vis Spectrophotometer, Elemental analysis by atomic emission spectroscopy,TLC, Malvern Mastersizer, Dissolution, Karl fisher, TOC, Viscometer, Polarimetry, Fluorimeter, 3 –star Portable Conductivity meter and Spectroflurophotometer, HPLC(Waters 2795,Shimadzu 2010A), with chromatographic .

Data acquisition software like Empower, Totalchrom and Turbochrom

Laboratory information management system (LIMS)

Stability LIMS. Scientific Data Management system (SDMS).

Laboratory Incubators and Stability Chambers. High-tech systems for incubation – both heating and cooling, humidity and light control

Computer knowledge: Windows 98/00/XP,MS Office 95/98/00/XP (MS Word,Exacel)

EXPERIENCE:

Pfizer- Pharmaceutical (Department of Quality Control), Rocky Mount, NC

QC/QA Data Review Chemist (August 2012-Present)

Performed timely data review with a high focus on data quality to ensure accuracy, completeness, cGMP compliance, and neatness of analytical documentation.

Review / approve GMP related documents (SOPs, protocols, annual reports supporting production activities – environmental monitoring, personnel monitoring, cleaning monitoring, annual equipment and facility reviews)

Verify calculations and documented information such as reagent expiry, instrument calibration, logbook entries, control charts, etc. are present, completed and accurate. Verify and ensure all analysis performed are as per methodology and/or compendial methods, and are in compliance with GMP requirements.

Review the data entered in the LIMS for require data review and QA release support scientific,

Conduct routine audits of all equipment qualifications, Out of tolerances, calibrations, etc Assist as needed in facility/lab inspections and data audits and reports in a timely manner, ensure corrective actions are satisfactorily completed and issue QA reports as required.

GMPs; sample management; experience with monitoring and upkeep of validated temperature controlled units; and FDA and ICH guidelines concerning stability issues.

Initiate, track, and maintain with accuracy a variety of documents used in support of Manufacturing Operations or Research & Development.

Monitoring and maintenance of QO Stability chambers and data entry to ensure successful management of all ongoing studies.

Documents initiated, reviewed, and/or maintained include batch production records (BPRs), standard operating procedures (SOPs), logbooks, product technical complaints (PTCs), manufacturing and raw material purchase specifications, contractor badge access, training, and qualification forms, metrics or tracking spreadsheets/charts, various weekly/monthly/quarterly reports.

ACTAVIS INC., Totowa, NJ Dec. 1999 to June 2010.

Chemist (III)

Well versed with wet and instrumental analysis (HPLC, UV-VIS, Dissolution, FTIR, AAS, KF, TLC, Refractometer) of Raw materials, In process, Finished and Stability products and packaging components are accurately analyzed following analytical methodology, and USP and cGMP requirements testing. Troubleshooting and initial investigative work related to OOS, OOT.

Performs process validation analysis includes Blend testing, Dissolution Profiles, extensive Content Uniformity testing, Assay, Related compounds, Limit test and generates process validation reports.

Assist other departments in Analytical method validation and method transfer test analysis and generates validation reports. Assist with validation and R&D activities such as cleaning validation and swab samples preparation.

Well experienced with the calibration of all analytical instruments including Dissolution, Spectrophotometer, Bulk/Tap density tester, Friabilator, PH meter, extractions, and balances. Performs Daily Monitoring of Purified Water System (ELGA).

Preparation, documentation and maintenance of chemical test solutions and standards.

Responsible for trouble shooting and assisting manager investigating out of specification results.

Preparing standards to run routine tests for water purification system for the plant such as TOC.

Reviewed and revised SOP’s trained new employee in quality control department.

Working with Waste management QC Lab. And Handle and dispose of hazardous and non-hazardous chemical waste storage room and weekly inspections of hazardous waste containers on the OSHA Hazard communication standard.

Perform detailed data review for analytical test results generated by QC department for compliance with cGMP, internal SOPs and Specifications to support production, stability studies and lab operation. Stability support for products generation of stability protocols, review and analysis of incoming data, and authoring annual Stability reviews.

I will work with Product Quality Management/Manufacturing/Technical, Quality Supply Chain/Research and Development to conduct and resolve investigations of unexpected stability data.

Review release and stability data, trend charts of reference standards, lab equipment calibration records and log-books and other review function as needed.

Maintain and update relevant SOPs for data review and reporting as needed.

Maintain clean working environment by establishing and complying with procedural regulation.

Maintains laboratory work using laboratory notebooks with cGLP, cGMP requirement.

EDUCATIONAL QUALIFICATION:

Master of Science (Chemistry) S.P University, INDIA 1992.

Bachelor of Science (Chemistry) V.P Patel. Science Collage, INDIA 1990.

1.PUBLICATION: Synthesis, characterization and antimicrobial activity of Ni(II),Cu(II),Zn(II), and Cd(II)…with ternary complex.

SYNTH.RECT.INORG.MET.ORG.CHEM., USA.

2.Synthesis, structure determination and antimicrobial activity of Eu (II), Dy (II) and Tm(II)…with heterochalatas with 2,2- bipyridylamine+ catechol. Complex.

SYNTH.RECT.INORG.MET.ORG.CHEM., USA.



Contact this candidate