Quality Control Supervisor

DHIREN SHAH

***** ****** ***** *****, ******, MI-48187

Phone: (Home): 734-***-****

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

QUALIFICTIONS

Over twenty years experience as a Quality Control Chemist in the Pharmaceutical and Fertilizer/Petrochemical

Industries. Demonstrated success working in the pharmaceutical environment satisfying all requirements.

Familiar with compliance specifications within SOP, cGMP, GLP guideline, controlled substances and FDA

regulations. Ability to perform qualitative and quantitative analysis of in-process, finished, and stability

products using instruments such as HPLC, UPLC,GC, Dissolution, UV-Spectrophotometer, pH meter,

Disintegration, and K.F. Conduct investigations and prepare required documentation. Implement remedial

actions for Out of Specification (OOS), Out of Trend (OOT) results, or deviation from procedure and laboratory

investigation. Work independently or in a team environment with the to supervise and lead daily activities as

well projects.

PROFESSIONAL EXPERIENCE

Sun Pharmaceuticals Industries, INC, Detroit, MI, USA 2005-2014

Stability Supervisor 2010- 2014

• Supervised and managed daily activities of three Analytical chemists.

• Ensured the proper analysis of lab samples and coordinate testing priorities with other departments.

• Troubleshoot laboratory instrumentations issues and train laboratory employees as required.

• Provided back up assistance in performing laboratory testing using UPLC, HPLC, Dissolution, and UV-

Vis analysis.

• Performed reviewing, interpretation and trending of data on commercial product, stability samples, and

finished products in accordance with cGMP.

• Coordinated and documented deviations, investigation and OOS.

• Notified QC management of any discrepancy testing or OOS/OOT and atypical results.

• Ensured cGMP Compliance of all activates performed in Quality Control Laboratory.

• Performed daily data review activities and stability release activities.

• Audited the laboratory for cGMP/GLP compliance activities in accordance with SOPs.

• Monitored training plan and matrix as required, ensuring compliance and staff proficiency.

Quality Control Chemist-II / III 2005- 2010

• Worked in the Quality Control Laboratory for generics in solid dosage forms.

• Worked in Quality Control Environment and Validate HPLC analytical method for Related Substances,

Assay, Content uniformity, Blend uniformity, LOD, K.F, and Dissolution.

• Performed analytical testing for development sample following FDA and USP guidelines.

• Learned the quality system and practices of the company and gained an in depth understanding of

cGMP, cGLP, SOPs and chemical manufacturing norms.

• Performed analysis of stability and ANDA Stability samples on HPLC, UV, Dissolution, Photo Stability

and K.F Instrument for water content.

• Conducted Dissolution, UV/Vis and Calibrate the instrument according to SOPs.

• Trained on HPLC towards setting up the system, reviewing, processing and calculating data according

to SOPs and ability to use Empower software.

• Performed data review and provided troubleshooting expertise for the chemist in the laboratory.

• Performed data calculation and data analysis using Validated Excel spreadsheets.

• Notified QC Supervisor for any discrepancy testing or out of specification result.

• Maintained the records of MSDS and Certificate of Analysis.

Gujarat state Fertilizer & Chemical Ltd. Vadodara, Gujarat, India . 1992-2003

Oil and Natural Gas Commission, Surat, Gujarat, India. 1990 -1992

Senior Analyst (QC)

• Conducted physical & chemical analysis of raw materials prior to production of finished products.

• Tested air, water, gas and chemical samples as well as documenting and reporting results to plant

Personnel.

• Handled preparation and standardization of all laboratory reagents, normal solution, and indicators used

in the laboratory.

• Performed chemical analysis using wet analysis, Chromatography (GC & HPLC), spectrophotometer

(UV-Vis), K.F, Auto Titrator, pH meter, and Conductivity Meter.

• Maintained and complied with health and safety standards, Good Manufacturing Practices (GMP),

Good Laboratory Practices (GLP) and regulatory requirements.

• Carried out wastewater analysis for COD, BOD, TS, TDS, Alkalinity and Hardness.

• Ordered laboratory chemical and testing equipment.

EDUCATION

Masters of Science in Organic Chemistry, Gujarat University, India 1990

Successfully completed GMP training given by Lachman Consultants.

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