NAYAN PATHAK
South Plainfield, NJ 07080
Home: 908-***-****; Cell: 908-***-****
E-mail: *********@*****.***
OBJECTIVE: Ability to manage, lead or participate on a short, medium or long-term projects within the FDA regulated industries on documentation, Quality Assurance, auditing, method and process validation, calibrations, workflow analysis and efficiency enhancement projects.
SKILLS SUMMARY:
* Karl-Fischer reagent for moisture
* PH analysis
* Density
* Distillation
* Administration
* Microsoft office
* Report Preparation
EXPERIENCE:
PARAM HEALTHCARE & IT SERVICES,INC., ISELIN, N September 2012 to March 2014
Healthcare Coordinat
* Responsible for providing health education and counseling to the clients.
* Coordinating health & medical services with clinical team and RN to needed services.
* Providing all patients, Clinical, CHHA and needed documentation as regulated under CAHC accreditation.
* Responsible for insurance authorization, eligibility verification.
* Providing Marketing analysis and liaison between health care providers and organization.
ARCHONE VITAMINE, EDISION, NJ August 2011 – May 2013
QC Inspector
* Monitor and observe operations to ensure that they meet production standards.
* Inspect, test, or measure materials being produced.
* Measure product with rulers, calipers, gauges and micrometers.
* Responsible to make decision on remove all materials and products that fail to meet specifications.
* Responsible for batch record reconciliation.
AMNEAL PHARMACEUTICAL, PATERSON, NJ January 2008 – May 2009
QA Inspector
* Raw material sampling, testing and pharmacy dispensing inspection and in-process manufacture.
* Inspection, in-process packaging and inspection as a cGMP.
* Label control system, batch record review and issuing.
RICHA CORPORATION, EDISON,NJ May 2004 – February 2007
Manager
* Prepare report and audit production as standard processor.
* Performed inspection for the stores, account, payroll, consumer compliance and supervise employees.
NUTRA MED,INC. RAHWAY, NJ November 2002 – May 2004
QA Inspector
* Develop and revise SOPs, review of documents including internal and contract manufacturer documentation to ensure GLP and GMP compliance.
* Perform and develop audits of quality control, contract manufacturers.
* Perform in-process testing on various products using standard operating procedures and comply with company standards under FDA and GMP regulations.
* Process and labeling/packaging operations for compliance to cGMP’s and company policies and procedures.
Swakrut Enterprise, Sayreville, NJ November 1996- November 2002
Manager, Krauzer Food Store
* Controlling store operations, finance, Human Resource, customer services
* Responsible for store operation and inventory.
LINI, INC. RAHWAY, NJ April 1994 – November 1996
QA Inspector
* Disposition in-process materials, verify and approve labels.
* Review of batch documentation for compliance to cGMP and SOPs.
* Perform the final product inspection and product shipment approvals.
ABLE LABORATORY, SOUTHPLAINFIELD, NJ February 1990 – April 1994
QA Inspector
* Process and labeling/packaging operations for compliance to a cGMP’s and company policies and procedures.
* Assisted in the preparation of internal audit reports, participating in QA projects and representing QA on project teams.
* Reviewed batch documentation for compliance ensuring all investigations and deviations are addressed prior to product release.
EDUCATION:
* Middlesex Country Vocational & Technical Schools, NJ Pharmacy Technician Certification 2009-2010.
* Certificate of Pharmacy Technician, NJ
* Gujarat Ayurved University, Gujarat, India
Bachelor in Ayurved Medicine and Surgery- BSAM, MCS
References: Available upon request.