Quality Assurance Medical

Resume of Kalpana Desai

SUMMARY:

Graduate from Accredited Nursing School in U.S. possessing a valid RN

license. Certified in US in Clinical Safety Surveillance, Post marketing

Pharmacovigilance, Drug & Device Development Regulations and Medical

Coding. Fourteen years of clinical experience as a practicing physician in

India. Eight years of experience in the US Pharmaceutical Industry as a

cGMP Document Control Specialist, Logistic Expert, QA Associate, and

Packaging Supervisor.

EXPERIENCE:

Merck Pharmaceuticals, Summit, NJ

January 2011 to June 2011

Documentation Specialist, PSCS

. Job duties included processing and archiving documents submitted to

Pharmaceutical Sciences & Clinical Supplies Department.

. Reviewing GXP documents for completeness.

. Data entry, updating database, and tracking documents.

. Scanning and posting images to SharePoint.

. Issuing Lab Notebooks

Schering Plough Research Institute/Merck Pharmaceuticals, Summit, NJ

Aug 2009 to June 2010

Documentation Specialist

. Worked as a SOP administrator in Pharmaceutical Sciences Documentation

Department.

. Handled requests for revisions as well as new SOPs. Functions

included reviewing, formatting,

sending documents for approvals, issuing, and making the

documents effective.

. Conducted filing and archiving of GMP documents..

. Updated Database and tracked documents.

Union County College, Union, NJ

September 2008 -Dec. 2008

Peer Tutor

. Worked as a peer tutor for Anatomy & Physiology, Medical

Terminology, and Basic Chemistry.

PAR Pharmaceutical Companies, Somerset, NJ

July 2005 to December 2008

Document Control Specialist/Lab Support Specialist

. Coordinated all cGMP related data and documentation for PAR

Pharmaceuticals Somerset facility in support of forty plus

development projects. This included R&D, QC, and QA release data.

All documents were filed and tracked for accuracy and completeness.

. Created database and maintained electronic records of all cGMP

documents submitted to the cGMP Documentation area.

. Presented documents at the time of FDA pre and post approval

inspections and successfully supported thirteen (13) PAIs leading

to ANDA approvals.

. Received accolades from both PAR management and FDA inspectors on

the accuracy of records archival and retrieval programs developed

and implemented in the cGMP Documentation area at PAR.

. Supported Lab Functions by keeping inventory of all chemicals

and supplies. Negotiated prices with vendors for lab supplies and

equipments.

Able Laboratories, South Plainfield NJ

December 2003-May 2005

Packaging Supervisor

. Handled the responsibilities of Packaging Supervisor for second

shift packaging; had about 22 packaging personnel reporting to me.

. Planned and conducted Packaging activities to achieve monthly

production target.

. Reviewed packaging Batch records for completion and accuracy.

. Conducted SOP and cGMP training sessions for Packaging Personnel.

. Participated in formatting as well as revising packaging SOPs.

Able Laboratories, South Plainfield NJ

March 2003-December 2003

Quality Assurance Inspector

. Worked as a QA inspector in the Production Department to monitor

various activities such as blending, compression, encapsulation,

coating, and packaging.

. Promoted as a Packaging Supervisor on the basis of Excellence in

performance.

Eckerd Pharmacy, South Plainfield, NJ

September 2002 - March 2003

Pharmacy Technician

. Assisted the pharmacist in processing prescriptions as well as

insurance claims.

Family Physician, Mumbai, India

April 1987 - December 2000

. Worked as a PCP at Sagun Clinic.

. Duties involved Assessment, Diagnosis, and Treatment of patients.

. Followed up patients and made necessary referrals.

Attending/Resident Physician, A. N. Desai Maternity Hospital, Malad, Mumbai

March 1986 - Feb 1987

. Attended patients in Outpatient Department.

. Admitted patients and supervised care of admitted patients.

. Assisted in minor surgeries.

Resident Physician; Trainee - Harjivan Hospital, Pune, India

August 1985- Feb 1986

. Provided care to admitted patients.

. Was trained on various aspects of patient care.

EDUCATION:

. RN - Graduate from Muhlenberg Nursing School, Plainfield, NJ USA

. L.C.E.H.; 12 + 4 years Degree in Homeopathic Medical Sciences &

Biochemistry from CMPH Medical College, Mumbai India

. Certified in US in Clinical Safety Surveillance, Post marketing

Pharmacovigilance & Drug Device Development Regulations.

. Certified from Middlesex County College in Medical Coding.

. Trained End -user of Documentum and J.D. Edwards.

. Certified in Microsoft Word, Excel, Access and PowerPoint.

CONTACT:

Phone: (H) - 732-***-****

(C) - 732-***-****

WORK AUTHORIZATION STATUS: US Citizen. E-mail:

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

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