Quality Control Manager

Career Objective:

To obtain a challenging management position that will utilize my

professional and educational background and allow for career growth

and continuous development

within the Pharmaceutical industry.

Summary of Qualification:

. 19 years of strong Analytical Quality Control Pharmaceutical

Laboratory experience including management of stability & product

release groups.

. Handling & troubleshooting of instrument malfunctions and conducting

laboratory investigations to reach scientifically sound conclusions

with effective CAPA.

. Expertise in various forms of chromatography as well as many other

analytical techniques. Comfortable working in a pressure filled

environment to meet commitments for release of data and submission of

ANDAs.

. Developed methods and performed analysis of active pharmaceutical

ingredients, New Chemical Entity (NCE's), and formulated products.

Experience on separation and isolation of impurities by preparative

HPLC, present in low concentration.

Professional Experience:

Dec 2009 to Present Teva Pharmaceuticals (API),

Mexico, MO, 65265

QC Manager

. Oversee day-to-day activity of the Quality Control Department. Manage

6 individuals in a laboratory that consists of Finished Product,

Stability & R & D activity.

. Maintain flow of testing and release for incoming components, and

final samples, including development and stability studies.

. Perform training and manage the performance of the Quality Control

Laboratory group.

. Guide and review the laboratory investigation of out of specification

(OOS), out of trend (OOT), atypical results. Ensure that laboratory

investigations reports include root-cause analysis and timely

completion.

. Manage responses to customer and internal audits. Responsible to

support QA for customer complaint analysis of the products;

communicate with QA and provide report to customer.

. Review and approve SOPs, Analytical Method, Method Validations and

stability reports.

. Evaluate In-house Analytical method with compendial method and manage

require testing and reports.

. Manage budget of the department and plan for the upcoming year.

Major achievements and participations at Teva Pharmaceuticals:

. During February 2012, supported to Associate director Quality during

inspections by the FDA as subject matter expert and successfully

maintained QC Department within required compliance (no observation

from FDA).

. Manage internal audit performed by QA and Global compliance related to

laboratory compliance.

Jan 2007 to Dec 2009 Caraco Pharmaceutical Laboratory Ltd. Detroit,

MI, 48202

Manager

. Main responsibilities involved overseeing the Quality Control

Department. Management of more than 22 individuals in a laboratory

that consists of Finished Product, QC Stability & AD Stability groups.

. Day-to-day duties included support of R&D and QC by overseeing

analytical testing and release for incoming components, and final

samples. This included in-process testing, final product testing,

development studies, stability support & clinical release.

. Responsible for ensuring the precision, accuracy and reliability of

the company's drug products in compliance with all applicable federal

and international regulations and standards according to the FDA's

Quality System Regulation (QSR), Code of Federal Regulations (CFR),

cGMP's, GLP's, the USP and any international regulatory.

. Trained and managed the performance of the Quality Control Laboratory

group. Take priority in solving mechanical and analytical chemistry

problems. Complete the laboratory out of specification (OOS), out of

trend (OOT) atypical results investigation, and ensure that root-cause

analysis and timely completion of laboratory investigations reports.

. Managed and worked on any critical situations and notified Regulatory

Department in a timely manner.

. Built and led cross-functional teams, time and budget management,

influencing and working well with others in a proactive and

constructive manner, communicating clearly, in both verbal and written

forms, within all levels of the organization. Consistently used

written and verbal communication/presentation skills along with strong

team leadership experience and motivational skills.

Major achievements and participations during Caraco Employment:

. Supported Sr. Manager during inspections by the FDA two times; during

May 2006 and May 2008 and successfully maintained QC Department within

required compliance (no observation from FDA).

. Handled audits performed internally, by consultants and by customers

related to laboratory compliance.

. Continuous contributions in improving quality, productivity,

compliance, training, communications and cost saving projects.

. Attended several training sessions on management skills that were

conducted, internally, by HR.

Dec. 2002 to Jan 2007 Caraco Pharmaceutical Laboratory Ltd. Detroit,

MI, 48202

Various Positions as Chemist to Stability

Supervisor.

. Major activities during this time included testing / supervision of

the ANDA exhibit batches, stability analysis, Raw material and

development Samples, conducting phase I and phase II laboratory

investigations, data review, release, writing and reviewing of SOP's

and STP's.

. Instrument IQ, OQ and PQ reports, and the training of new chemists.

Managed various groups within the Stability group.

. Coordinated with QC Manager to manage, supervise and schedule ANDA

exhibit batches to meet Bio - study dates and release of stability and

development samples as per requirements.

. Ensured proper Quality Control Documentation on a routine basis for

cGMP / cGLP compliance.

. Coordinated with method validation / transfer group for

troubleshooting in analytical procedures.

June 1997 to April 2002 Sun Pharmaceuticals

Industries Ltd. Baroda, India.

Research

Officer.

. Literature survey (of assigned projects) for HPLC method development

for intermediates and finish products.

. Developed methods and provided timely analysis for intermediates and

finish products with the assistance from individual group leader (or

scientist) from organic synthesis and analytical department.

. Separation / Isolation of impurities present in low concentration by

Preparative HPLC for DMF / FDA requirements.

. Provided analytical support during scale-up operations at different

plant locations for R&D projects when required.

Achievements:

. Promoted to Research Officer from Research Assistant.

. Isolation of impurities from different drug substances.

. Analytical method development of various kinds of New Chemical Entity

in initial stage.

May 1995 to May 1997 Vitara Chemicals Ltd., Nandesari,

India.

Junior Analyst .

. Analyzed Raw materials, intermediates and finish products using

different analytical techniques.

. Analyzed effluent treated water for chemical Oxygen Demand.

. Follow up with cGLP guidelines and work on ISO Documentation.

Sept. 1994 to April 1995 Khatau Junker Ltd., Ankleshwar,

India.

Chemist.

. Analyzed raw materials intermediates and finish products using wet

chemistry, GC etc.

. Performed in process analysis and keep control during plant process.

August 1993 to August 1994 Elecon Engg. Co. Ltd., Vallabh Vidyanagar,

India.

Trainee Chemist.

Skills:

. Knowledgeable in cGMP and cGLP requirements, ICH guidelines and

Federal Regulations

. Experience in several laboratory techniques, including HPLC using

Empower2 software, GC, UV-Vis, Polarimetery, Dissolution, as well as

various wet chemistry techniques

. Knowledgeable in using Microsoft Word, Excel, and Power point, LIMS.

Also familiar with Lotus Notes and Open Office.

. Trained in Management and Team Leading Skills

. Trained in performing and reviewing investigations in accordance with

FDA guidelines

Education:

. Post B.Sc. Diploma (In Analytical Chemistry)

1994.

Department of Chemistry,

Vallabh Vidyanagar, India.

Sardar Patel University.

. B.Sc. (Chemistry)

1993.

VP & RPTP Science College,

Vallabh Vidyanagar, India.

Sardar Patel University.

Reference: Available upon request.

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