Rupal Patel

(732) 329-1858 / (732) 979-0221 23 Monica Way, Monmouth Junction New Jersey 08852

rpat31@hotmail.com

 

 

Proficient Quality Specialist, capable of handling a wide range of Quality Operation/Complaint functions which consistently produces top-quality work. Proactive, professional with years of experience in a quality regulated environment. Strong process improvement background and excellent leadership skills to resolve quality issues. Bright, efficient and flexible team player that possesses excellent interpersonal skills and is accustomed to a fast paced environment. Experienced in handling complex projects and multiple activities simultaneously, while prioritizing in order to meet aggressive deadlines.

 

 

    AREAS OF EXPERTISE

 

·       ELISA ·       SDS ,HCV 3.0Riba Chiron ,Western Blot assay, Electrophoresis ·       Stability of new and commercialized products

·       Track wise ·       OTIS ·       Reagent and software integration on instrument system ·       Siebel and PTC data base, SAP.

 

 

PROFESSIONAL EXPERIENCE

Sanofi Pharmaceuticals October 2014 – November 2015 (Pro-Unlimited)

Documentation Specialist II, Sanofi Cold Chain Hand Sampling Support –US Quality and Compliance.

 

·   Maintaining CCHS equipment inventory and manual equipment change authorization process.

·   Assemble/analyze all supporting documents for internal review.

·   Coordinate receipt of TMD acceptance documents and prepare for Q & C authorization

·   Work with Sample Optimization partner on remediation of issues, when applicable including:

·   Coordinate all documentation associated with the Sales Professional Certification Program and prepare for Q & C authorization to receive samples and begin sampling

·   Review equipment qualification test documentation, including calibration records, to support equipment releases for GMP use.

·   Maintain supplier and Sales Professional relationships to ensure good program communication, proper receipt of documentation and to provide guidance or direction on program objectives.

·   Perform administrative functions to support documentation filing, storage and retrieval 

·   Provide continuous support for additional product launches of other cold chain products to be hand sampled.

·   Perform other special projects as needed.

 

 

Bristol-Myers Squibb October 2013 to July 2014

  Complaint Analyst II

·   Physical receipt, triage and investigation of product complaints received on site.

·   Investigations are hands on with returned product, visual and functional in nature and include data entry into Track wise databases.

·   Process no product return complaints, as paper-based, from various databases. Investigate and input data entry into various databases.

·   Follow up with contract service providers, including call center, return pack vendor and others as needed.

·   Review, approve and close complaint cases.

 

Sanofi Pharmaceuticals 2011- 2013 (Cognizant)

 Complaint Analyst

·   Support the Product Quality Complaints Department through the implementation of the applicable regulations, company standards, and department SOPs for the evaluation and investigation of certain, defined technical complaints received on medical devices, Drugs and Pharmaceuticals. 

·   Determines if an inquiry is a Product Technical Complaint (PTC) or if it’s a Non-PTC and can either be resolved or closed. And reviews those inquire in Siebel database for completeness and accuracy.

·   Involved in the field alert process and works closely with the Anti-counterfeiting group to look for cases which may trigger a field alert and/or may be suspected counterfeit cases.

·   Works closely with US Pharmacovigilance (USPV) in the classifications of a case and sends cases back to USPV to be re-evaluated if necessary.

·   Responsible for AE cases and Non AE cases closures.

·   Contact the reporter of the product technical complaint for any additional information that is required and document within Siebel database.

·   Responsible for selecting the site of investigation, assigning case categories, complaint phrases and sample status for product technical complaints based on information that was obtained from the reporter of the product technical complaint.

·   Manages the proxies all cases are handled in to ensure they are handled in a timely manner according to FDA guidelines. Provides the necessary changes to individual schedules so cases are moved through the proxies without any delays.

·   Handles potential expedite cases such as drug counterfeiting, fake and/or manipulation cases. Also any critical cases which can cause severe immediate harm or death to a consumer. Screens trigger words for those cases in triage to make sure they are addressed immediately.

·   Collaborates when necessary with internal affiliates, external sites, customer service, call centers and Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management.

·   Performs file review and closeout for individual complaints.

·   Produces and sends monthly reports to responsible manufacturing sites listing monthly complaint activity.

·   Monitors open complaint activity for each manufacturing site.

·   Proficiency with computer applications including Microsoft Word, Excel, and PowerPoint.

 

JOHNSON & JOHNSON, OCD Division, Raritan, NJ 1998 – 2010

Scientist II

                           

 

·       Collaborated in the testing of raw materials and final products using different instrumentation in the donor screening laboratory to help release the final product in the laboratory.

·       Performed batch record review to verify compliance to GMP.

·       Implemented an automated instrument system in the QA Release Testing Laboratory so that any issues seen at the customer site would be identified by the Release Testing lab.  This action has helped reduce customer complaints. 

·       Ensured  internal guidelines were met during the execution of spreadsheet validations.

·       Participated in successful audit by FDA and external auditors providing requested data.

·       Quality Representative for Donor Screening  marketed product stability program.

·       Qualify critical raw materials with ELISA, SDS and Electrophoresis. Support manufacturing of products and maintain inventory of the same.

·       Trained and certified staff on the operation, maintenance and troubleshooting of the OAS/OSP system in AHQA laboratory for compliance and successful operation. Extensive knowledge on assay performance and release criteria. Executed release testing, maintained release files, performed release data trending.

·       Thorough knowledge of Specs and test methods.

·       Experienced with LIMS system.

·       Responsible for marketed product stability program.

·       Distribute Monthly stability report to QA Laboratory, Chemistry and Microbiology, Ensure all testing performed by appropriate laboratories.

·       Review stability test results for completeness on monthly basis.

·       Ensure GMP compliance, maintenance, and calibration of release laboratory instrumentation and work area.

·       Analyze and resolve internal and external customer complaints. Write failure investigation reports.

·       Perform QA release testing for blood-screening products used by the American Red Cross and major blood centers.

·       Performs all maintenance and Verification on the OSP instruments.

·       Perform testing on OEM product

 

Blood Center of NJ               East Orange, NJ 1997-1998                        

Clinical Laboratory Technician

 

·       Proficient in all viral assays – HbsAg, HCV, HIV I & II, P24 Antigen, HTVL-I/II & Anti HBC. Instrument utilized included Abbott PPC, FPC.

·       Performed daily QC on all instruments.

·       Troubleshoot assays and equipment, prepare daily reports.

 

New York Blood Center        New York, NY 1990-1997

Clinical Laboratory Technician

 

·       Worked and maintained Ortho and Abbott instrumentation.

·       Proficient in all viral assays HbsAg, HCV, HIV I & II, P24, Antigen, Anti HBC & HTVL-I/II AB capture. Utilize instrument like Abbott PPC, FPC, and ortho summit, washer, reader.

·       Performed daily QC on all instruments.

·       Trained new laboratory staff.

·       Troubleshoot assays and equipment, prepared daily reports.

·       Responsible for separation of blood into various components, labeling and dispositions of blood components

 

Education 1984 - 1988     Sarder Patel University               Gujarat, India ·       B.S. Microbiology