Quality Assurance Control

UMAKANT A. SHAH

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

Danbury, CT 06811

203-***-**** *****@****.***

PROFILE

Quality Assurance professional with extensive experience, known for

ensuring compliance with cGMP and company policies, procedures and

specifications. Perform incoming sampling and inspection of products.

Proven results in controlled drugs handling, operation and transfer

activities. Final audit of Batch Manufacturing Records and relevant data

entries. JD Edwards operation for inventory management. Built reputation

for problem solving and collaborating effectively with team to achieve

tight deadlines with highest quality.

PROFESSIONAL EXPERIENCE

WATSON LABORATORIES, INC., Carmel NY 1989-2010

Quality Assurance Inspector-IV

Performed incoming sampling and inspection of products. Final BMR audits.

Monthly retain inspections and disposition. Draft and revise standard

operating procedures (SOP). Trained and qualified new employees. Engaged

in special projects and execution of protocols.

Carried out leadership and training functions in accordance with

organization's policies and procedures as well as state, federal and local

laws.

Monitored executions of sampling and inspection procedures for compliance

with product item code and current policies.

Credited for training two existing and new employees in all phases of

manufacturing areas as a Line Trainer.

Performed Physical Testing such as Particle size analysis, Bulk/Tap

density, Disintegration, Loss on drying and Friability on various products.

Developed and implemented quality assurance, SOPs and forms required by the

procedures.

Worked closely with Supervisor for any deviation, incident and/or non-

conforming situations and assisted in the investigation and internal audit

programs.

Led and completed special projects and complex protocols as assigned with

proven results.

Credited for controlled drugs retain transfer activities to another

facility in a highly regulated environment with 100% accuracy.

Indepth accuracy of BMR auditing and data entry.

Known for problem solving and collaborating effectively with team to meet

tight deadlines with high quality and compliance standards.

High ability of effectively communicating technical information to peers.

JD Edwards operation for inventory management.

Knowledge of:

Current Good Manufacturing Practices (cGMPs), Standard Operating Procedures

(SOPs) and Food and Drug Administration (FDA) and other regulatory

compliance regulations and standards.

Quality Control practices in the Pharmaceutical industry.

Leadership, project management and training methods and techniques.

Sample techniques and method of assigned areas.

Label procedures and techniques.

Business, scientific and personal computer hardware and software

applications.

Principles of mathematical and statistical computations.

Current company policies, practices and procedures, including safety

regulations.

Skilled in:

Reading, reviewing, sampling, counting and maintaining inventories and logs

for materials in assigned areas.

Reading, interpreting and complying with current company policies and

procedures including safety regulation.

Coordinating and delegating assignments and reviewing the work of assigned

department personnel.

Communicating clearly and concisely both orally and in writing.

Operating personal computer and database software.

Establishing and maintaining cooperative working relationships with peers.

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