Quality Control Assurance

Usha Patel

* ******* ****

Telephone: 732-***-****

Edison, New Jersey 08820

E-mail: ********@*****.***

Summary

Senior level Quality Control/Assurance professional with expertise,

performing third party audits, review and release raw materials, bulk

products, in-process, and stability analytical data, batch records,

packaging component and label review to ensure compliance with GMP, GLP

regulations, act as team to launch new drug, participate in method -

transfer, qualification and validation protocol, data and report review,

revise SOPs and test methods, supervise controlled drug substance and

quality reviewers, chemists, finished product release schedule, prioritize

multiple work assignments and deadlines. Review and revise procedural

documents. Initiated change control request, revise raw material

certificate of analysis to harmonize with USP/NF, train employees on revise

documents and annual GMP training, participate in investigations related to

quality incidents, approve investigation reports and associated CAPAs.

. Team leadership and management

. Knowledge of regulatory guideline (cGMP)

. Excellent writing, organizational, presentation skills

. Relationship building and interviewing skills

. Customer complaint - investigation

. Batch record review

. Document Control

. Six Sigma (Green Belt Training)

. SAP

. Experience working with FDA and other regulatory agencies

. Contract manufacture audit experience

. Reference standard program

. Packaging components /Test data review and release, Change Control

Education

. Drug Development Program Certification - Temple University School of

Pharmacy

. QA/RA Basic Study Program Certification - Temple University School of

Pharmacy

. ASQ Quality Auditor Certification

. Environmental Inspector Certification (CEI)

. Environmental Specialist Certification (CES)

. Microbiology Certification

. B.S. Chemistry - Bombay University, Bombay, India

Training

. GMP requirements for Pharmaceutical Drug Product and Pharmaceutical Bulk

Chemicals

. ISO 9000 Internal Auditor and Document Control Training

. Quality Auditor Fundamentals Training

. Quality Engineering Certification Review

. Water Empower Training

. Analytical Method Validation Training

. Design of experiments in analytical laboratory

Professional Experience

CorePharma - Middlesex, NJ 2007 - 2013

Senior Quality Supervisor Direct reports: 5

(2008 - 2013)

Served in a QA/QC capacity. Supervised three lab data reviewers, one

Controlled drug substance coordinator and one QC administrator. Developed

reference standard program. Provided assurance, that systems and processes

assure the efficient operation of laboratory. Facilitate continual

improvement of standard operating procedures by revising biannually.

. Managed laboratory personnel involved in performing routine testing of

Raw Materials, bulk, in-process and stability samples. Met aggressive

project timelines for release as per business plan

. Established and maintained the mechanism to assure that products are

tested and evaluated in accordance with cGMP regulations, and other

applicable requirements (e.g. USP and ANDA provisions) and conducted

investigations of OOS/OOT results and customer complaints

. Partnered with the Document Control, Regulatory Compliance, and

Regulatory Affairs departments to assure compliance to applicable

regulations for revision to approved procedures and completion of CAPA

intended to assure ongoing improvement in quality systems and processes.

. Ensured personnel employ current Good Manufacturing Practices (cGMP),

their responsibilities as defined under 21 CFR Part 211.22

(responsibility of the Quality Control Unit) and that subordinates are

qualified by virtue of education, training, and experience for their

assigned tasks and activities

. Provided performance feedback to staff, conducted periodic performance

reviews, and encouraged/supported them for career development

Third Party Lead Auditor Direct Reports: 5

(2007 - 2008)

Teamed with management to accomplish the commitments made to regulatory

agencies to complete and prepare the audit report (which included review of

QC laboratory records of the past five years, laboratory note books,

chromatographic HPLC/GC raw data, audit trail, instrument calibration and

qualification data, reports and stability samples).

. Selected auditors based on subject matter expertise and developed

strategy to audit the documents

. Developed documents and procedures (SOP) to conduct audit

. Monitored regular process of the audit and gather findings and forwarded

management

. Lead and monitor implementation of corrective actions and improvements

Pfizer Inc. (NutraSweet/Searle/Pharmacia/Pfizer)

1996 - 2007

Pfizer Global Manufacturing - Morris Plains, NJ

(2003 - 2007)

Product and Process Development Scientist

. Supported reformulation projects, design of experiment project and

stability samples

. Developed methods to determine surface area of API for material

characterization analysis on BET surface area analyzer

. Analyzed continuous dry granulation samples and vitamin B complex syrup

and tablets

. Reviewed department's SOPs, audited lab notebook and raw data

Searle /Pharmacia Global Pharmaceutical Technology - Mt. Prospect, IL

(2000 - 2003)

Validation Specialist

Participated in technology transfer method qualification /validation as a

result of Pharmacia acquiring Searle Pharmaceutical.

. Reviewed method qualification, validation, transfer, and process

validation protocols and reports

. Supported team to prepare submission documents for NDA/ANDA/SNDA

. Authored, reviewed, implemented, and updated departmental SOPs.

. Participated in departmental internal audit and regulatory inspection

Searle, Monsanto Life Sciences Co. - Mt. Prospect, IL Direct report:

2 (1998 - 2000)

Global Quality Assurance and Compliance Specialist

Planned, performed and audited bulk drug product Cox-2 received from Puerto

Rico, primary and secondary packaging components, labels release documents

and a production area at contract manufactures facility. Awarded with

decent incentive.

. Managed two QA Associates/ QA Samplers and trained newly hired QA

Specialists.

. Ensured integrity and control of documentation related to clinical,

stability and contract manufactured batch records. Conducted annual

product review.

. Reviewed and approved the pharmaceutical products, raw materials and

packaging components in accordance with approved procedures,

specifications, SOPs and cGMP for pharmaceutical technology and contract

manufactured products

. Reviewed investigation reports, create vendor corrective actions and

supplemental data reports. Communicated with management and achieved a

satisfactory resolution. Coordinated annual SOP review program and

provided QA decision on document control issues

. Investigated and responded to customer complaints in a timely manner

. Coordinated the Pharmaceutical Technology Pilot Plant Environmental

Monitoring Program

. Supported multi-site activities toward COX-2 launch

NutraSweet Kelco Co., Monsanto Life Sciences Co. - Mt. Prospect, IL

(1996 - 1998)

Quality Compliance Auditor

Responsible for reviewing analytical data for new products testing and

related stability and stability data of marketed products

. Developed and implemented SOPs within the analytical compliance group-R&D

and reference standard

. Reviewed and approved validation of analytical methods in compliance with

cGMP and GLPs for food additive petition

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