Quality Assurance

JANVI CHOKSHI

*** *. ******** ******, ***# A***, Sunnyvale, CA-94085. Contact# 408-***-****

************@*****.***

SUMMARY OF QUALIFICATION:

Quality professional with seven years of experience in management and marketing. Experience in testing and managing quality of raw materials, finished goods and packaging in Pharmaceuticals. Expertise in quality assurance, manufacturing, document controlling and compliance. Knowledge about implementation of Six Sigma tools and Lean manufacturing tools. PROFESSIONAL EXPERIENCE

Quality Analyst, Relypsa Inc., Redwood City, California, Aug’16 – Oct’16

• Execute corrective and preventive actions program (CAPAs) for investigating and resolving issues.

• Involve in Drug substance as well as Drug Substance Intermediate Batch releasing process

• Support EDMS electronic documentation management system for Batch release process

• Create QA Batch Disposition Checklist and QA Disposition Certificate

• List out process related Deviations and Change Controls batch wise

• Create Risk Assessment against each process related manufacturing change control

• Participate in the internal audit program and mock inspection QA Intern, Relypsa Inc., Redwood City, California, May’16 – Aug’16

• Manage and update lot genealogy for Drug substance and Drug substance intermediate

• Create Risk Assessment against manufacturing change controls

• Review vendor’s documents/binders to check results are within quality specifications and create Executed Batch Record review

• Involved in Drug substance as well as Drug product Batch releasing process • Supported in issuing Disposition Certificate for Drug Substance

• Create and update OOS/OOT, CCRs, Deviations and CAPA spreadsheets for FDA inspection Project Coordinator, Farmers Insurance, San Jose, California, Aug‘12 – May’16

• Responsible to maintain customer and commercial relationship

• Responsible to track status, negotiate contract terms and generate Service Level Agreements

• Recognized root cause and removed barriers to avoid claims and assure high quality outcome

• Initiated corrective actions and managed litigated workers ‘compensation, property and liability claims

• Maintained knowledge of regulatory & procedural policies Accomplishments include:

Ø Introduced streamlined processes and procedures for managing insurance clients, resulting in an increased customer retention rate of 13% for Property and Casualty Insurance. Ø Drove a pace-setting with 23% increase in annual revenue in 2013-14 for Workers

‘compensation Insurance.

Marketing Representative, USV Pharmaceuticals, Ahmedabad, Gujarat, Jun ‘10 – Nov ‘11

• Established significant relationships and communicated with approximately 150 Physicians- Surgeons in-person presenting them about enhanced quality and benefits of products of the company

• Coordinated & managed activities associated with selling pharmaceutical drugs and inventory management worth of $145K.

• Provided marketing reports about status of current market and local demographics

• Developed teamwork in order to improve operational processes and achieve business goals

• Strategic planning to achieve 11% growth target annually

• Demonstrated ability of cold calling and goal oriented Accomplishments include:

Ø Top ranked marketing representative nationwide for selling highest number (2500/monthly) of BrainStar Tablets in 2011

Ø Top ranked marketing representative state level for selling highest number (4510/monthly) of Amlopin-M Tablets in 2010

Trainee, Zydus Cadila Pharmaceuticals Pvt Ltd, Ahmedabad, Gujarat, Oct ‘09 – June ‘10

• Reviewed and managed Scrap Reduction and Quality Auditing to ensure the quality and consistency of raw materials

• Analyzed Statistical Process Controls (SPC) to assure medicine manufacturing process is in control

• Reviewed and followed Master Batch Records to ensure manufacturing process is accurate and complete

• Reviewed and managed quality of Packaging and Dispensing strips of tablets manufactured, and make sure quality is maintained

EDUCATION

California State University Dominguez Hills, CA Master of Quality Assurance (Manufacturing) B. S. Patel Institute of Pharmacy, Mehsana, India Bachelor of Pharmacy

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