Quality Control Customer Service

Bhavesh Patel e-mail: ****************@*****.***

***** ******** *****, ******, **, 48187 Phone# 313-***-****

Objective To join an organization with an opportunity available to utilize my background and talents for

quality results. To employ my diverse experience and aptitude for learning new systems,

towards the current organizational needs. To take on responsibilities involving risk, making

necessary decisions and taking the action necessary/ required to meet organizational goals.

Management / supervision of a program or division within a department is desired.

Experience

Summary Mange independently laboratory discrepancy system. Perform investigation and

documentation for Primary work history in area of analytical chemistry, in both industrial and

pharmaceutical environment as a analyst, group leader and supervisor. Principle expertise

in managing laboratory productivity, turnaround goals with work priority for Quality Control

that accurately reflect product and customer service release needs. Independently perform

laboratory investigation and documentation for out of specification (OOS), out of trend

(OOT). Mange to keep track of projects, training to new chemists, troubleshooting of

instruments and support the analytical activity.

Additional capabilities and broad experience with internal audit to keep laboratory in

compliance state with SOP, DEA, FDA and cGMP. Perform subordinate performance

appraisal. Strong theoretical and practical background in analytical and organic chemistry

with advanced skills using HPLC, GC, spectrophotometer and other instruments commonly

used in analytical laboratory.

Experience with many software and documentation laboratory automation system, including

waters millennium/Empower and Microsoft office products.

Professional Caraco Pharmaceutical Lab. LTD, Detroit (May 2000- present)

Experience QC supervisor

Employed as the first shift supervisor for the US pharmaceutical quality control. Caraco

pharmaceutical manufacture solid dosage generic drugs.

Quality control Supervisor, First Shift (May 2005-present)

• Directly responsible for Supervising group of 14 analytical chemist, 2 group leader

and a data checker as well report directly report to Quality control Manager.

• Ensure time lines and appropriate sense of urgency in all aspects of Quality Control

functions and laboratory productivity and turnaround goals are met. Establish work

priorities for Quality Control that accurately reflect product and customer service

release needs. Review of test results and final documentation for issuance of

certificate of analysis for product released.

• Schedule testing planning for production process validation samples and prepare

final QC report for production process validation.

• Revise and update documentation as required to support regulatory changes, audit

findings, new equipment and new procedures.

• Mange laboratory discrepancy system. Participate in laboratory discrepancy system

for quality control testing. Perform investigation and documentation, issue CAPAs as

needed and implement remedial actions for out of specification (OOS) or out of

trend (OOT) results, deviation from procedure and laboratory investigations.

• Directly maintain control substance samples record and inventory.

• Prior to released the drug product, reviewed, audited, checked and released with

cGMP aspect.

• Perform internal Laboratory audits and method assessments to keep lab in a

compliance cGMP state and audit ready for upcoming FDA inspections.

QC Group leader (Chemist-III) May 2004- May 2005

• Supervise analytical chemists in analytical testing, finish product sample receipt,

testing planning and QC support functions. Responsible for prepared worked

schedule for finished product and stability testing.

• Provided expertise, guidance and Advance phase training to chemist. Troubleshoot

all lab equipment and interprets the Chromatography.

• Timely notify QC supervisor for any discrepancy testing or out of specification

results.

Chemist II May 2000 – May 2004

• Performed analysis of Raw Materials, Intermediate & Finished products on HPLC,

UV, FTIR, DISSOLUTION, auto titration, and KF instrument for water content.

Validation of the analytical methods developed in-house or pharmacopoeias, which

covered Linearity, method precision, accuracy, robustness and ruggedness. Review

and audit of the analytical data generated during analytical methods validations and

development for accuracy, adequacy and compliance with protocols. Perform

Dissolution with performing a sustained release and controlled release study.

• Calibration of dissolution bath and UV-Visible instrument and Maintain calibration

record .

• Maintained lab waste management system. Demonstrated experience in analyzing,

interpreting and solving problems.

INDU NISSAN OXO CHE. IND. LTD. (ISO 9002), INDIA ( 1992 -1997)

chemist (Quality control)

Performed analysis of raw materials, intermediate, finished products and catalysts

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using gas chromatography, UV spectrophotometer, karl-fischer, distillation unit and

chemical analysis.

Maintain daily and monthly lab. Results reports.

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Planing of lab. Maintenance and coordinated maintenance plans between various

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departments.

Committed to maintain quality and efficiency.

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Education: M.Sc. in Chemistry (Sardar Patel University,India)

B.Sc. in Chemistry (Sardar Patel University,India)

Additional 2002- Waters millennium seminar.

Professional 2002- Trained for safety procedures for safe handling of chemicals.

Development 2004- Technique for technical writing of investigation.

2005 -Attend seminar in Business writing skills organized by skill path.

2007- Supervisory Skill workshop.

2009- Hazardous waste management seminar.

References Available Upon request.

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