Management Quality Assurance

NAYNA GOHEL (Ma Nitya Harikanta)

** ****** ***** ****, ***** Brunswick, NJ 08902

732-***-**** (H)

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

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OBJECTIVE:

To obtain a position in a scientific field, which utilizes my skills,

offers growth and provides an environment of learning in Biotechnology or

Pharmaceutical environment.

SUMMARY:

> Over 17 years of experience in Clinical Research, Validation,

Quality assurance in diagnostics and Biotechnology and

Pharmaceutical environment.

> Experience includes projects management for the validation of

laboratory equipment, computer validation and IT compliance,

Process validation, and Biotech/Environment/Quality

System/Regulatory - validation.

> Demonstrated familiarity with regulatory compliance for agencies

like the FDA, OECD, EPA and EU/EMEA.

> Computerized systems with 21 CFR Part 11 compliance and validation

include specialized training, compliance assessments and validation

of various systems.

EXPERIENCE:

ICON Contracting Solution (JNJ-OCDUS, Raritan, NJ)

09/08 - Present

Clinical Scientist

. Experience with Clinical Trials Phase 0, I, II, III and IV and studies

Immunology, Colon Cancer, Heart Failure and Lung cancer

. Under supervision of the project leader, plans and executes clinical

studies of varying complexity in support of FDA 1572, PMA and

financial discloser submissions and international registrations. Work

within US and international regulatory guidelines, QSR and GCP

. Designs clinical study forms and manages version control. Develops

site management and monitoring plans and participates in clinical

sample acquisition and clinical study implementation. Assists in

identification and selection of principal investigators and clinical

study sites. Assist in preparation of clinical study agreements and

clinical site budgets

. Work with key opinion leaders/Investigators

. Prepare site training materials, prepare study binders (Regulatory,

Data and Training)

. Collaborate with Clinical Data Manager to develop data collection

tools (DCTs)/Case Report Forms (CRFs)/Informed Consent Forms

(ICFs)/Minor Assent Forms, Study Questionnaires, design Study forms,

develop and Utilize tracking tools

. Be able to problem solve and advise team members where to seek answers

to questions about technical issues as required

. Participate with ICS and OCD management in the selection of additional

team member as required

. Conduct/facilitate site training (GCP, regulatory Binder, Generic

study process)

. Collect Essential documents, maintain Trial master file, Coordinate

Site payment

. Mange Study Materials including but not limited to: Kits and reagents

tracking/shipping and reorder

. Equipment and study sample logistics

. Monitor Study sites, including site initiation visit, Interim

Monitoring visit, Close Out visit and associated reports, communicate

with study sites

. Serve as a librarian - Technical library (Scientific literature

filing)

. Technical writing e.g. draft documents of PEP (Performance evaluation

plan), Study protocol, Study management plan, Sample Management plan

and Summary reports)

. Represent the company and the organization adequately in working with

external parties (e.g. CROs) and travel for work about more than 30%

. Protect the company assets and rights, particularly information on IP

as the key asset

. Conduct business in line with the Health care compliance, company

credo, policies and procedures, including applicable SOPs

. Maintain adequate communication with relevant parties within and

outside the company

. Comply with ICH-GCP and all applicable local, state and federal laws

and regulations

. Actively complete required trainings to ensure adequate qualification

for performing job related tasks

. Report (suspicion of )fraud or scientific/ethical misconduct as

appropriate

. Regularly update information in applicable systems and templates

. Contribute to the development and improvement of departmental

procedure and processes and templates in the scope of the company's

effort towards continuous quality improvement

. Maintain quality standard and timeline that are consistent with

business needs

Huntingdon Life Sciences (CRO), East Millstone, NJ 08873

System Specialist

03/08- 09/08

. Perform inspection of computerized system and assay validation

documentation during validation/qualification activities, change

control and ongoing maintenance of systems to the applicable

regulations and SOPs. Prompt reporting of findings to study and

facility management and resolution of issues

. Perform assigned facility and vendor inspections in a timely manner.

Active participant of MARSQA and SQA. Performs any other duties as

required or assigned. Participates on site wide

validation/qualification teams. Reports to study management on

facility and study compliance issues regarding the use of computerized

systems

. Good understanding of IT infrastructure and systems, and system

development life cycle (SDLC). Familiar with Documentum (Tracs

system), Rees Environmental Monitoring System, Watson (LIMS), other

Laboratory applications (e.g. Librate, Analyst, ClynaxysII) and MS

Office applications

. Obtain and provide training (e.g. SOPs) on an annual basis and

maintain training records as new procedures becomes effective. Assure

compliance with all SOPs, US regulations and international regulations

guidelines, company policies and procedures

AtPharma Inc., Princeton, NJ 08540

Validation Consultant - (JNJ - PRD, Raritan, NJ)

01/06- 01/08

. Write and review validation protocols (IQ, OQ, PQ) including URS (User

Requirement Specifications), CSV (Computer System Validation) related

risk assessment, test scripts, test summary reports, data migration,

pre/post execution, and traceability matrices. Write summary reports

of qualification/re-qualification activities. Good understanding of IT

infrastructure and systems, and system development life cycle (SDLC)

. Obtain knowledge of Documentum (PhramaDoc and EDMS) and Track Wise

(Spectrum) from Sparta, MS Office applications, Chromatographic Data

Management System (CDMS) and other Laboratory applications (e.g.

CyberLAB, Millenium32 and Empower)

. Proven track record for completion of complex projects within budget

and on time. Detail-oriented, self-motivated and able to manage

multiple priorities and effectively communicate with team members and

management

. Assure compliance with all SOPs, Pharmaceutical regulations, FDA

regulations such as 21 CFR Part 11, 210, 211, 58, 820 and GXP (GMP,

GLP, and GCP), ICH, USP and European regulations (EPA, OECD)

guidelines, all company policies, and procedures

Ortho Clinical Diagnostics (JNJ), Raritan, NJ 08869

Immunologist, Bio-formulations/Operations

3/02 -1/06

. Planned, designed and performed validation protocol of equipments and

products. Familiar with cGMP, GLP, 21 CFR part 11, work related SOPs

and OSHA regulations

. Developed and implemented new processes for current and new products,

and raw material procedures in formulation and manufacturing.

Developed and improved test methods, testing designs, execution and

documentation of studies

. Monitored Laboratory workload of routine and non-routine analysis of

chemical and biochemical methods. Analyzed and reviewed data using

software such as Empower and Chemstation.

. Used scientific expertise to provide assistance to coworkers in

troubleshooting, laboratory investigations and problem resolution.

Performed AMAPS transactions to assure accuracy of inventory

. Evaluated data to detect product or method-related trends. Worked

independently but ensured communication of critical information upward

with management

Bio-Reference Laboratory, Elmwood Park, NJ 07407

Assistant Supervisor

5/98 - 3/02

Medical Technologist

1/95 - 5/98

. Worked in areas such as Immunology, Cancer Analysis, Therapeutic Drug

Monitoring, Drugs of abuse and PCR Techniques

C&S Clinical Diagnostics, Englewood, NJ 07631

Medical Technologist

5/92 - 12/94

Clinpath Laboratory, Bloomfield, NJ 07003

Medical Technician 1/91 -

3/92

BIo Technology Skills: PCR (Molecular Biological), ELISA, Chromatographic

Techniques, RIA, EIA Techniques, Microbiological Techniques and

Validation Techniques

FAMILIAR EQUIPMENT / INSTRUMENTS: Most lab equipments such as HPLC, GCMS,

LCMS, LTQ, OSP (Ortho Summit Processor), FTIR, UV/VIS Spectrometer etc.

Education: B.S. Microbiology, Saurastra University (India)

Certificates: Six Sigma, Process Excellence and TrackWise (Spectrum)

Computer Skills: MS Windows, Internet, MS Office, Visio, SQL, SAS,

Oracle, Citrix, Spectrum and Documentum

. References: Provided upon request.

Contact this candidate