Quality Control/ Assurance

AJAYKUMAR PATEL

* **** ******, *******, **-*****

Contact: 201-***-**** Email: ********@*****.***

Summary:

Six year of thorough experience in Pharmaceutical and Bio-pharmaceutical manufacturing industry to serve patient

Effective work and time management skills with sound work ethics to get work done under tremendous pressure

Strong analytical and troubleshooting skills with excellent experience in pharma and Bio Pharma Quality department.

Experienced in Aseptic transfer, culturing techniques, autoclave, microbiological assay and other analytical techniques

Skilled in using Microsoft Project, Track wise, Empower chromatography and Laboratory information management systems

Excellent team player who works well with the team and related departments to make the projects successful for company

Thorough and well-spoken leader with clear communication skills to present project plans to all levels of professionals both internally and in a conference setting to achieve goals set by the organization

Member of ISPE (International society of pharmaceutical Engineer)

Professional work:

Norwich Pharmaceuticals

Quality Control Team Leader- March 2014 to Current

Productivity:

Serve as a primary resource for planning and scheduling of tests, Assist analyst as needed in troubleshoots Instrumentations and Methods

Provides support for ordering and inventory of laboratory materials

Initiate the Change Control, Event Notification and Deviation according to Standard Procedure and applied Corrective and Preventive action

Review the testing results, create CofA and Release finished products using System Application Products (SAP) system

Develops, Revise, Review and Implement Standard operating procedures

Performed method development, qualification, verification or validation according to established SOP’s

Prepare and review Method Validation protocols/reports and QC Methods

Manages new product, method and technology transfers

Prepares yearly goals and objectives for direct reports, Prepares performance evaluation for direct reports

Identify and implement process improvements that will reduce cycle time to test and release products

Safety:

Participate in safety training and Identify potential safety hazards

Implement appropriate safety improvement and investigate safety related incidents

Compliance:

Ensure that the laboratory test is performed in compliance with cGMP requirements, current industry standards, FDA expectation and internal procedures

Reviews and approve Deviation, Validation reports and Corrective and Preventive Action

Performed regular Internal Audits, Risk Assessment and conduct Customer Complaints according to SOP

Ensure laboratory investigations are conducted in timely manner and are completed within established dates

Conduct the Quality and Standard Operating Procedure training for the new and existing employees

Norwich Pharmaceuticals

Quality Control Chemist-May2011 to Feb2014 (2 years 10 months)

Supported master data generation project for Empower 3 chromatography data acquisition system integration

Developed and generated master data templates for new and existing QC test methods for lab systems

Prepared reagents, standards, media needed for analysis according to established methods

Supported QC CAPA and Nonconformance using Track wise to prepare labs to remain compliant to Regulatory requirements

Performed Analysis of the sample by HPLC, GC and Spectroscopy according to SOPs and cGMP regulations

Performed other tests including Process Validation Sample, Analytical Method transfer, Cleaning Validation, Sampling, and all other analytical work in Quality Control Lab

Interprets and tabulates results of analysis. Records the results in approved notebooks, iStability and SAP system

Develop and execute protocol for automated dissolution apparatus, HPLC and Spectroscopy

Performs Calibrations, Standardization’s, and routine maintenance of instrumentation as

Supported in developing, writing and reviewing Standard operating procedures and Reports

Reviewed quality control data for compliance to specifications and procedures, and reporting abnormalities

Executed protocols and assay procedures in support of method validation, instrument qualification and stability studies

Restech Pharmaceutical Pvt. Ltd.

Quality Control Chemist- April2007 to Oct2007 (7 Months)

Inspected Incoming raw material, In process, Finished Product and Cleaning verification samples and create Documentation

Participated in standardization test like disintegration, dissolution, hardness and friability testing

Performed calibration of the lab equipment such as PH meter, weighing scale, Disintegration test apparatus

Prepared standard reagent and kept inventory up to date. Swab sampling procedure for cleaning validation studies

Kept documents according to GLP guidelines and filled up Log files regularly and kept it updated

Restech Pharmaceuticals Pvt Ltd.

Manufacturing Associate-Jan2003 to Nov2003 (11Months)

Performed blending and granulation using planetary mixture, V cone Blender and fluid bed granulator

Produced Tablets using Rotary Tablet Press for commercial batch using standard Operating Procedure

Operated Capsule Filling and Polishing using capsule filler with the SA-9 semi automatic machine

Excellent experience with both Film and sugar coating for the batch using large scale coating pan

Obtained sound understanding of Manufacturing Batch records and developed process for cGMP Manufacturing

Assisted in documentation like SOP’s application and standardization, analytical procedures and manufacturing procedures

Education:

Stevens Institute of Technology

Master of Science in Pharmaceutical Manufacturing -Jan 2008 to May2010-GPA: 3.4

Pharmaceutical Manufacturing Certificates:

Pharmaceutical Manufacturing Practices (PMP)

An introductory overview of the industry, touching on all basic manufacturing processes, facilities design issues, validation and regulatory affairs concepts which drive the industry

Bioprocess Systems in Pharm. Mfg. (BSPM)

Includes overall facilities issues, biotechnology processes, specific Bio-Pharma facilities design concepts, and sterile facilities approaches

Project Engineering in Pharm. Mfg. (PEPM)

Includes the overall discipline view of facilities design, a formal introduction to project management concepts, specific implementation concepts for sterile facilities, and the newer PAT( Process Analytical Technology) concepts

Rajiv Gandhi University of Health Sciences

Bachelor of Pharmacy- Jan2004 to Dec2006-GPA: 3.5

Pharmaceutical chemistry & applied biochemistry. Pharmaceutical Engineering

Pharmaceutical microbiology & biotechnology. Pharmacology & Clinical pharmacy

Graduate projects:

Prepared Standard Operating Procedure for Concentration of the recombinant Protein by using Ultra Filtration and Di Filtration

Prepared Maintenance Verification Protocol for Tablet Packaging line

Facility Design Tablet manufacturing Facility as per cGMP requirement which includes gowning layout, HVAC zoning, Material flow, air lock, space allocation

References Available upon Request

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