Quality Assurance Control

GRISHMA PATEL, M.S., RAC

Address: *** **** **** **, *** # 416

Contact # 1-201-***-****

Salisbury, MD 21804

Email: **********@*****.***

Summary:

A qualified Graduate with Bachelors' in Pharmaceutical Sciences, Masters'

in Pharmaceutical Chemistry and possessing US-Regulatory Affairs

Certification (RAC). An experienced Quality Auditor with effective

communication, excellent and strong team building ability, good analytical

and problem solving skills and ability to efficiently manage competing

priorities to achieve maximum level of effectiveness.

An active member of the team facing various successful regulatory audits

like USFDA, ANVISA, AFSSAPS and audits from sponsor companies.

In depth knowledge of US-Regulatory Affairs demonstrated by scoring 84% in

US-RAC. Possess thorough understanding of Investigational New Drug

Application (IND), Investigational Device Exemption (IDE), New Drug

Application (NDA) and Abbreviated New Drug Application (ANDA) process.

Responsibilities included review and audit of all data related to NDA and

ANDA studies, the final compiled reports for regulatory submission,

instrument calibration and validation reports, conduct in-process audits,

system audits, maintain document control system, develop and review

Standard Operating Procedures (SOPs), maintain change control system,

resolve and respond to FDA/Sponsor queries.

Have attended various training programs for effective communication, time

management and leadership qualities and other technical training programs.

Extensive experience in three sectors of pharmaceutical field:

Nutraceutical quality assurance (2 years and 6 months)

Regulatory auditor with Lambda Therapeutic research (Clinical Research

Organization) (3 Years)

Parenteral production-quality assurance / quality control (5 months)

Work Experience:

Tishcon Corporation, USA (Nutraceuticals)

Quality Assurance -GMP Specialist (Jan 2010 - Present)

Job Responsibilities:

. Raw material and finished product sampling for quality control testing

. Instrument release for production as well as routine in-process checks

for compliance with batch records

. Raw material and finished product assay for minerals and heavy metals

by ICP-MS

. Maintain a document system: Change control, SOPs and CAPA etc

. Ensure regular training of staff on GMP and related issues and

maintain all the training records

. Handle customer complaints by co-coordinating with responsible QC

personnel

. Conduct internal audits on regular basis

Lambda Therapeutic Research Ltd., India (Clinical Research Organization)

GLP-Specialist (QA Auditor) (Dec 2004 - Jan 2008)

Job Responsibilities:

. Review and audit of all the data pertaining to the bio-analytical

portion of ANDA and NDA submissions (Therapeutic and non-therapeutic

clinical trials):

> Study protocols, bio-analytical reports, source data, method

validation and method development

> Chromatographic data through electronic database system (SDMS)

> Calibration records and validation documents of all instruments

and equipment's

> System related documents like log books and other GLP activities

. In-process audits of bio-analytical phases of clinical trial projects

and method validation

. Review and prepare QA SOPs, method SOPs and bio-analytical related

system SOPs for adequacy, correctness and completeness

. Maintaining documentation and records including all Change controls,

SOP revision, SOP/protocol deviation

. Train the QA staff for performing QA activities efficiently

. Resolve any discrepancies related to bio-analytical section and

communicate with Regulatory Agencies and Sponsors

. Selection of vendor for instruments and its calibration as per the

SOPs and re-audit at regular intervals

Marck Parenteral (I) Ltd., India

QA/QC Chemist (July 2004 - Dec 2004)

Job Responsibilities:

. Perform microbiological sterility tests, LAL test and analytical tests

(UV absorbance, pH, Solubility, polarity etc.) for raw materials,

finished parenteral products and water for injections (WFI) in order

to ensure safety and quality

. Perform line-clearance (QA Checks) for the release of finished

products

. Perform agar plating and plate counting in production areas (Cleaning

Validation)

Skills and knowledge:

Skills:

. Achieve the timelines while maintaining excellent results

. Able to lead the team efficiently as well as work independently

. Good communication and presentation skills

. Detail oriented, able to plan and prioritize a broad range of

responsibilities in order to achieve maximum level of effectiveness

Knowledge:

. Sound knowledge of the USFDA Regulations, principles of GLP, GMP, GCP

and other Guidelines

. Knowledge of Code of Federal Regulations (21CFR) concerned with IND,

IDE, NDA and ANDAs

. Fine-tuned with operation of MS Office Suite, internet search engines

and scientific databases

Education:

MS in Pharmaceutical Chemistry

Fairleigh Dickinson University, Madison, NJ, United States

GPA: 3.812 (on a 4-point scale)

Bachelor of Pharmacy (April 2003)

K.B. Institute of Pharmaceutical Education and Research, Gandhinagar,

Gujarat, India

GPA: 3.860 (on a 4-point scale)

Relevant course work:

Statistical Analysis Software Programming (SAS), Graduate Seminar, Method

Development in HPLC

Certifications / Membership of Professional Associations:

Regulatory Affairs Professional Society

Possess US-RAC

State Pharmacy Council - Gujarat, India

References:

Reference details shall be provided on request.

Contact this candidate