Quality Assurance Control

KEERTHI KEERTHI

***-* ******* *****, **********, Massachusetts, 01803, (Cell) 781 552

****, acc7ui@r.postjobfree.com

HIGHLIGHTS OF QUALIFICATIONS

. Worked full time night shift as a lab technologist in Lantheus Medical

Imaging

. Undergraduate research project with Professor Lever to study the

electrochemical reduction of carbon dioxide by Ruthenium compounds

. Excellent analytical skills and experience working with HPLC, UV

Spectrometer, FTIR, cyclic voltammetry and rotating disk techniques

. Extremely meticulous and detail oriented with exceptional ability to

communicate, resolve conflicts and collaborate with others in

multidisciplinary teams

. Proficient in Microsoft Windows, Microsoft Access, Empower software,

Chem Draw and Mercury

EDUCATION

Pharmaceutical Quality Assurance and Quality Control Post Graduate

Diploma December 2012

Toronto Institute of Pharmaceutical Technology, Toronto

Bachelor of Science, Specialized Honours Chemistry

April 2011

Faculty of Science and Engineering

York University, Toronto

PHARMACEUTICAL EXPERIENCE

Quality Control and Quality Assurance (laboratory work)

. Hands on experience in performing the Compendial tests such as

Friability test, Disintegration test, Uniformity of content of active

ingredient (Uniformity of weight & Content uniformity)

. Dissolution test

. In house tests such as Hardness test, Appearance test

. Knowledge and operation of UV Visible spectroscopy

. Knowledge and operation of High Performance Liquid Chromatography

. Infrared Spectroscopy (FTIR)

Method Development and Method Validation

. Performed method development and also created a development report of

Caffeine tablet 200 mg and Theophylline (RC)

. Created validation protocol to validate the HPLC method for the

analysis of Caffeine and its related compound (RC) in Caffeine tablet

(200 mg)

. Conducted method validation to validate a high-performance liquid

chromatographic (HPLC) for the analysis of Caffeine and Theophylline

in Caffeine tablet 200 mg

. Validation tests determined during validation are:

o Range, Specificity, Linearity, Accuracy, Precision, Robustness,

LOD and LOQ

. Created a validation report for Caffeine tablet (200 mg) which

incorporated all documented results

TIPT Projects

. Pharmacology project on the Anti hypertensive drug product, Norvasc

and its role in the treatment of the disease Hemorrhagic stroke.

Expert report on:

o dosage forms, strengths, route of administration, physical

properties, pharmocodynamics

o patent review and protection, packaging and labeling review,

pharmacokinetic review

o medical indications and contraindications, worldwide product

review

. Method development protocol of Naproxen tablet 250 mg by HPLC analysis

. Analytical method validation protocol of Diazepam tablet 50 mg by HPLC

analysis

. Stability protocol to observe how the quality of Naproxen tablet

(500mg, 250 mg and 200 mg) varies with time under the influence of

temperature, humidity and light and to establish the shelf life for it

Regulations and guidelines

. Food and Drugs Act and Regulations

. Good Manufacturing Practices (GMP) Guidelines

. United States Pharmacopeia-National Formulary (USP-NF)

. International Conference of Harmonization guidelines Q1A (R2)

Compliance/Documentation

. Wrote an SOP for the operation of the Ro-Tap to determine the particle

size distribution of bulk powder

. Wrote an SOP to describe the steps taken as part of the (PHASE I)

investigation of Out of Specification results

. Prepared a GMP checklist to inspect the TIPT pilot production plant

and the TIPT QC lab

. Performed an on-site audit of the TIPT pilot production plant and the

TIPT QC lab

. Prepared an Audit Report summarizing the observations and risk

classifications of the pilot plant the TIPT QC lab

WORK EXPERIENCE

Laboratory Technologist

Dec 2012 to July 2013

Lantheus Medical Imaging, Toronto, Canada

. Dispensed sterile radiopharmaceutical drugs for SPECT diagnostic

medical scans under uni-directional air flow units (UAFU's)

. Majority of the pharmaceuticals produced are prepared as unit doses

for sterile injection in hospitals/clinics.

. Performed QC procedures (radiochromotography) on finished

radiopharmaceutical products

. Complied with WHMIS, CNSC, TDG and Ministry of Environment (MOE)

regulations in day-to-day handling of radioactive and bio-hazardous

materials

. Practiced effective radiation safety techniques in compliance with

ALARA (As Low As Reasonably Achievable) principles during daily

routine

. Carried out a range of lab duties such: lab set-up, instrument

calibration (rate meters, Ludlum counters, scales, etc.), waste

disposal, inventory maintenance, shipping/receiving of raw materials

and finished products

. Worked within the guidelines and regulations of Transportation Canada,

Health Canada and Canadian Nuclear Safety Commission

. Maintained meticulous records of all aspects of business in compliance

with Canadian National Safety Committee (CNSC), Transportation of

Dangerous Goods (TDG) and Therapeutic Products Program (TPP)

regulations

. Maintain excellent customer relations while demonstrating urgency and

focus on meeting challenging deadlines.

Quality Control - Packaging Material Analyst

May 2011 to Dec 2011

Dr. Reddy Labs, Hyderabad, India

. Performed primary packing material testing (all types of Glass vials

and all types of Rubber closures)

. Performed printed packing material testing (like Labels, Cartons and

Leaflets).

. Performed tertiary packing material testing (Shippers, Cool packs and

EPS moulded boxes).

. Perform physical tests (drop test, static load test, visual quality,

etc.) as outlined in the packaging material specification to determine

the acceptability of the materials and in case of non-conformance

check causes of observed

. Maintained and kept quality records of all incoming packaging

materials and finished product batches. Stored, recorded and retained

samples in area accessible to quality audit.

. Conducted physical inspection of all returned finished goods that are

reported to have problem on packaging and recommend the appropriate

next step to correct and close the quality issue.

. Issued non-conformance notices with corresponding corrective actions

on the process that deviates and has significant impact to the

environment.

. Supported developmental works on product and packaging development

and vendor qualification under the new product commercialization

. Checked packaging for suitability and testing for performance under

various conditions

. Controlled production and quality standards

. Identified and chose products from suppliers

. Recorded and sometimes interpreted results to present to senior

colleagues

. Kept up to date with technical developments, especially those which

can save time and improve reliability

. Followed and ensured strict safety procedures and safety checks.

Cashier

Masafi Grocery, Dubai, U.A.E

May 2008 to July 2008

TRAINING AND PROFESSIONAL DEVELOPMENT

. Participated in regular training (SOP, GMP, GLP, various regulations,

TDG, etc) 2013

. Radiation Safety Techniques annually

2013

. First Aid and CPR techniques

2012

. WHMIS (The workplace Hazardous Material Information System Training)

2012

. Basic Security Officer training

2009

VOLUNTEER WORK

Volunteered for YAY (Youth Assisting Youth)

2011

. Provided peer mentoring service to improve life prospects for at risk

and

newcomer children at Non-profit charitable organization

. Volunteered at the workshops that identify and deal with issues on

cultural

diversity, mentoring, child management and child abuse awareness

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