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Quality Assurance Management

Location:
New York, New York, United States
Salary:
50000
Posted:
October 17, 2016

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RESUME

Yogeshkumar PATEL

***-** *** ******, ***-504

Flushing, NY, 11355

E-mail: acw3lj@r.postjobfree.com.

PH: 917-***-****

Objective:

Seeking scientific position in a creative and challenging environment where my multi-tasking approach, Quality Assurance and Regulatory knowledge can be utilized towards the growth of organization.

Skill Profile:

Quality Assurance professional with over 3 years of experience working in the pharmaceutical industry in US and abroad.

Have knowledge, skills and experience required for a Quality Assurance role along with excellent attention to detail, Manufacturing, Packaging, problem solving, team-building, and communication skills with an ability to deliver accurate and quality results.

Detailed Understanding of cGMP regulation and various regulatory body guidelines.

General understanding of various manufacturing, packaging operations, auditing

practices, laboratory controls and validation processes.

Ability to perform and manage multiple tasks.

Good technical and management skills, excellent problem solving skills.

Good computer skills, including proficiency in Ms Word & MS excel.

Very determined, willing to accept and gain knowledge of new things.

Work Experience:

3 Months as Chemist Training at Civil hospital., Ahmedabad, Gujarat, India

1 Year 6 months as Packaging Supervisor in Torrent Pharmaceuticals, Kalol Road, Gujarat, India.

6 Year 2 months as Chemist in Bhagyalaxmi Medical Stores, Vastrapur, Ahmedabad, Gujarat, India.

Quality Assurance associate: Ascent Pharmaceuticals, NY, U.S.A. (March 2014 – June 2015),

Senior Quality Assurance associate: Invagen pharmaceuticals, Hauppauge, NY (July 2015 –September 2016).

Job Responsibilities:

QA Systems and Documentations.

Preparation of Master art work for Labels, Pack Inserts and medication guides.

Ensure Annual Product Reviews, SOPs, Change Controls, Complaints, Investigations, CAPAs, Stability Management, IQ/OQ/PQ protocols and reports, and validation protocols and reports are managed in compliance with regulatory requirements

Performing in-process activities during execution of Commercial and ANDA batch packaging Operations.

Issue and control of printed packaging materials like labels, pack inserts and med guides.

Issue and control of Master batch packaging record (BPR). Scanning and updation of master BPR into electronic system whenever there is change in revision.

Updater daily transaction of material inventory card (related to packaging) into warehouse Inventory management system.

Perform Annual Visual inspection of Retention sample.

Co-ordinate with QA documentation and Regulatory team for filling of APQR Data.

Monitoring & Execution of Exhibit batches and Validation batches and in process samples at various stages of Packaging operations per Approved Protocol.

BPR Review and certification.

Reviewing of Installation, Operational and Performance Qualification Document.

Effectively handled market complaints with improved methods of investigation.

Handling of Deviations and Incidents.

Extended Key QA documentation support to Regulatory departments personnel for all

ANDA/Dossier applications.

Planning the requirements for the Packaging operation in co-ordination with the supply chain Management.

Preparation and Review of SOP’s and implementation of new procedures after approval.

Issue, control and retrieval of reserve (retention) samples of drug products and brand samples.

Contributes to team effort by accomplishing related results as needed.

Education:

Diploma in pharmacy: Rajiv Gandhi University, Bangalore, Karnataka, India (2005-2007).

References Available upon Request



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