SUMMARY

Quality Assurance Professional with rich experience utilizes collaborative and leadership style to create an environment of teamwork success. Efficiency, accuracy and commitment are my strength to my success. I live with a life philosophy, enjoys a work-life balance.

CAREER HISTORY

STI Components (VWR International) May 2017- Feb 2018

Specialist - Quality Assurance, Manufacturing:

Managing and developing Quality associates, administering employee discipline. Reviewing Performance Annual reviews.

Facilitating preparation and compilation of Quality assurance data.

Reviewing in-coming materials specification, certificate of conformance for release.

Reviewing Batch Manufacturing Records for assemblies builds.

Managing the internal process-based audit program, instrument calibration system, cGMP training program and pest control program.

Support provided for Customer Audit preparation and ISO certification Audit.

Conducting departmental training to associates to ensure the compliance with current ISO standards, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs).

Reviewing of investigations into non-conformances, closure of associated corrective and preventative actions (CAPA), and follow-up through effectiveness checks on CAPA

Handling Customer Complaints and initiating investigation report with root cause analysis and immediate CAPA actions.

Initiate and manages Customer, Supplier and Internal change control procedures.

Managing and maintaining database for the Quality system, process flow charts, and Quality Metrics per ISO 9001.

Novartis Nov 2009 – Oct 2015

QA Document Manager, Pharma: 2011 – 2015

Master user for ESOPS (Electronic Standard Operating Procedures System) for SOP management and training.

Developed and reviewed Technical documents (TEDI) and test code generation for GMP document repository.

Support provided to import Licenses processes.

Support provided for Global Quality Audit preparation and USFDA inspection.

Support Internal inspection for QA document reviews.

GMP assessment for outsourcing service providers for Novartis testing samples.

Key user for Novartis Inventory control system (iSupply Material management).

Recognitions

2014 Individual Achievement Award for ESOPS & TEDI Key user

2013 Team Award for Technical contribution to developing Automated tracking tool for Import License management

Quality Assurance Manager, Consumer Health: 2009 – 2011

Worked independently on-site at the Third Party as the liaison between Novartis manufacturing sites and the management and QA of the Third Party providing stability services.

Monitored the Qualification and Calibration of Walk-in Stability chambers.

Developed, implemented, and maintained procedures for the management of stability services at contract laboratories.

Managing the contract laboratory associates dedicated to Novartis work, and ensure their adequate training.

Conducted internal GCP auditing as per ICH guidelines.

Supported Computer validation and Method Verification program.

Review Sample management, stability protocol for Stability studies and

Monitored stability sample storage and testing per Novartis quality standards and meet ICH, GMP and global Health Authority requirements(GLIMS).

EDUCATION

Bachelor of Science (B.Sc.) from Mumbai University in 1987

Subject: Chemistry

City: Mumbai

Business of Management Administration (MBA) from Mumbai University in 2008

Subject: HR

City: Mumbai

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