KINA BIDJA

Email: acxs45@r.postjobfree.com Cell: 201-***-**** 99 Western Avenue, Jersey City, NJ, 07307

Objective: To obtain a challenging position in a Pharmaceutical company where I can utilize my Educational background, skills and intelligence for the growth of the company.

Experiences:-

Novartis Pharmaceuticals, Morris Plains, NJ

Quality Assurance Associate/clinical coordinator (March 2016 to Present)

Perform Batch Record Issuance for Internally Manufactured Products.

Issuance and verification of patient batch record.

Reviews and approves manufacturing and QC related Documents for Raw material Disposition.

Reviews and approves manufacturing and QC related documents for manufacturing media

Performs administrative functions for filling and maintenance of records between QA operations and Document Control Center.

Support cGMP and associated OJT training to QA and other Departments to improve right the first time (RTFT), high Quality Performance.

Follow cGMP Guidelines to maintain product Quality and cGMP compliance.

Knowledge of Data Management Electronic system like SAP (System, applications and product in data processing), LIMS (Laboratory information management system), Intralinks etc.

Create and investigate deviations using AQWA System

Review and maintenance of logbooks.

Communicate/Report deviations.

Knowledge of MES system

Walmart Pharmacy (June 2014 to Mar 2016), NORTH BERGEN, NJ

Pharmacy Technician

Preparation and Dispensing of Drug

Resolve problem Relating patient Insurance

Resolve problem Relating prescription

Maintain Patient Information As per HIPPA.

Maintain Log Copy Process

Stevens Pharmaceutical Research Center, HOBOKEN, NJ

Validation Engineer (Jan 2014 – June 2015)

Preparation and Execution of IQ, OQ and PQ Protocols

Knowledge of SDLC Life cycles and Models

Knowledge of different Gxp Regulations and GAMP categories

Preparation of URS,FS and Traceability Matrix

Execution of Validation Master plan, Validation protocols and FMEA

Generation and Evaluation of CAPA and SOP

Performing change controls

Knowledge about Regulatory Documentation and guidelines including GMP, GLP,ISO,21 CFR PART 11, 21 CFR PART 210,211,820

Prepare and Maintain Regulatory Submissions

Review and comparing current and emerging regulatory Requirements (e.g. US and international regulations and guidelines)

Preparation of Master Batch Record and Validation Summary Report

Perform Equipment validation

Preparation and Execution of Cleaning Validation Protocols

Development and Evaluation of Swab Sampling and Testing on TOC Analyzer for cleaning validation

Knowledge in determining cleaning MAC(maximum allowable carryover) limits to establish acceptance criteria for cleaning of Equipment

Knowledge of Statistical Tools like DOE, ANOVA, GAGE R&R

RPG Life Science, Gujarat, India

QA /QC Associate: (Aug 2012- Feb 2013)

Maintain batch manufacturing record

Supervised and Manufacturing of Tablets and Capsules

Perform change controls

Perform Quality Control test

Perform Regression Testing and Retesting

Perform testing on applications using both automated and manual testing methods

Conducted Failure Analysis of defective product

Communicate/Report deviations

Identify Compliance Risk / propose corrective action

Skills:

Analytical Skills:

Assay, dissolution, disintegration and testing of various drug formulation as well as lab scale preparation of various cosmetics such as shampoo, creams, ointment, tablets, and capsules.

Knowledge about HPLC, UV visible spectrophotometer, atomic absorption photometer, colorimeter, gas chromatography

Computer Skills:

Microsoft Office, M- Files, Minitab, MS Word, MS PowerPoint, MS Excel, SAP, LIMS

Education:

Master of Science (MS) in Pharmaceutical Manufacturing (Jan 2014- May 2015 ) GPA:3.699

Stevens Institute of Technology, Hoboken, NJ, 07047

Bachelor of Pharmacy (June 2008-May 2012) GPA: 3.7

SDPC, Gujarat, India

Relevant Certifications:-

1.Pharmaceutical Manufacturing Practices (PMP)

2.Validation and Regulatory Compliance (VRC)

3.Registered Pharmacy Technician

Educational Projects: validation project in Stevens’s institute of technology

Develop and Execution of IQ, OQ and PQ of glass washer, tablet press machine, blender, mixer.

Perform project relating six sigma, qPAT, validation risk assessment

Process development study and design of experiment for Pre-Blend.

Development of Fishbone diagram and FMEA

DOE for content uniformity method for HBD finished product.

Preparation of the Installation and Operational Qualification of Mixer.

Project on Implementation of QBD in global Pharmaceutical industry.

Performed Cleaning Validation activities by swab sampling using TOC analyzer.

Responsible for Preparation of various batch Manufacturing Record and protocols as per Cgmp.

Analyzed and Discussed Quality Trends observed in FDA Warning Letter

Area of Interest:

Process Validation

Computer Validation

Cleaning Validation

Quality Assurance

Regulatory Affair

References:

1)Manzano Annmarie

Associate director of QA OPS in Novartis

Cell: (201) -400-4792

2)Sweta Desai

Manager (for present job)

Cell: (201) - 213- 4476

3)Jennifer Maugle

Pharmacy Manager

Cell: (814) - 934- 9816

Email: acxs45@r.postjobfree.com

4)Choi Don

Pharmacist

Cell: (718) - 938-5747

Contact this candidate