Quality Control Assurance

TAZIN MAHNAJ

** ****** ****

Suffern, NY *****

Contacts: 845-***-****

*****.******@*****.***

SUMMARY

Research and Development Scientist with 15 years' experience in Analytical

R&D, Compliance, Quality Control and Quality Assurance of Pharmaceutical

Products. Experience includes method development, validation and

qualification of analytical procedures, stability study in compliant with

current FDA, ICH and other global regulatory guidelines. Data compilation

and review for accuracy, completeness and compliance. Review of protocol

and reports for final approval. Audit routine to complex pharmaceutical

projects for NDA/ANDA submission. Investigation of OOS/ OOT results for

reconstruction with objectives and scientifically sound details. Develop,

implement and enforcement of cGMP in the production batch review and

release processes. Interprets policies, standards, regulations, and

evaluate problems not covered by policies. In-depth knowledge in USP, BP,

EP and ICH guidelines, expertise in cGMP21 CFR Part 11, 58, 210 & 211

requirements. Follow GCP, OSHA, FDA, DEA guidelines, regulatory compliance,

and quality management policies

PROFESSIONAL EXPERIENCE

QA Specialist Pharmaceutical R&D Forest Research Institute (Subsidiary of

Forest Labs Inc.)

Commack, NY (January, 2013-Present)

? Analytical data review which entails performing specialty and technical

review to current products from preclinical development to products that is

ready for FDA review. Review results for accuracy and compliance.

Identifying issue, troubleshoot and initiate solutions to technical

problems

? Conduct performance review of analytical instruments, various stability

results, stability summary report, clinical study report, regulatory

submission documents etc.

? Review of reference standard qualification, raw material release,

recertification and finished product release. Excellent skills in reviewing

data through in LIMS, eNote Book, Empower, Totalchrom and Trackwise systems

Senior Scientist R&D/Compliance Altair Pharmaceuticals Inc.

Aquebogue, NY (Jan 2012 -

Dec. 2012)

? Develop, optimize and validate analytical methods for active

pharmaceutical ingredients and finish products. Perform drug substance and

drug product impurity characterization and identification

? Design and execute various types of storage stability studies as needed

for projects. Assist in managing stability program. Ensure investigation

and deviation associated with each record is addressed and closed prior to

final product release

? QA Audit of production systems, manufacturing and analytical departments,

approval of batch records, oversight the master formula and batch review

release function to ensure compliance and cGMP's

? Documentation review and change controls. Support product complaint

inspection and investigation. Assist training/orientation of new Quality

Auditing staff. Supervise QA Inspectors in daily quality control operations

including release, of raw materials, package components, bulk, and finished

product

? Assists in FDA inspections and internal audits by involvement in

inspection/audit discussion and by coordinating and ensuring supply of

required information and documentation in a timely manner. Audit entire

facility to get it ready for FDA inspections

R& D Compliance Auditor Hi-Tech Pharmacal

Inc. Amityville, NY

(July 2011- Dec 2011)

? Review of technical documents, Certificates of analysis, USP-NF test

methods, reference standard qualification reports, analytical test

procedures and change controls during product development life cycle

processes

? Review and approve CMC and non CMC related documents including product

specification, batch documentation, test method, analytical validation

report, method transfer, equipment qualification and calibration related

documents, process validation protocol and reports, stability and packaging

documents are in compliance with regulation for FDA filing

? Audits phase III analytical data for INDA/NDA submission. Review of

stability data and stability summary report for regulatory CMC submission.

Provide leadership in teaching and mentoring scientific staffs to ensure

that all facilities, equipment and personnel are and remain in compliance

with GLP / cGMP, FDA and EMA requirements

Senior R&D Compliance Auditor Teva Pharmaceuticals,

Pomona, NY

(May 2008 - Nov 2010)

? Audit analytical data for accuracy and compliance according to protocols

and test methods. Review transcription of data into reports; approve raw

materials and QA release. Evaluate the stability results and trends for

regulatory submission. Ensure release of numerous FDA approved products

timely to meet the deadlines

? Internal laboratory audits, discuss lab objects, identifying compliance

issues, laboratory investigations, deviations, change control, implementing

corrective actions to prevent them (CAPA) as well as monitoring the

internal quality systems to ensure compliance with GLP

? Audit IQ, OQ and PQ for instruments to ensure the accuracy, provide on-

going cGMP training for non-conformances. Provide QA/Compliance support for

project transfer to internal and external R&D sites.

Scientist II Barr

Pharmaceuticals Inc.

(Jan 1997- May 2008)

? Analytical method development and validation of raw materials and drug

products for Dissolution, Assays, Impurities/related compounds, Residual

solvents and stability indicating methods to co-ordinate the product

development activities of innovated drug products

? Performed vendor's method qualification, raw material release, bio-

equivalency in-vitro dissolution profiles for immediate and extended

release products. Process validation for scale up and bio/submission

batches. Perform cleaning validation for manufacturing equipments, in-house

standard qualification and calibration of analytical instruments. Authored

and executed method validation protocols and reports

? Stability testing for new drug products and monitored stability results,

identifying trends and write stability reports for ANDA submission. Assist

quality control department to modify and improve existing methods and

performed analytical method transfer to QC department

EDUCATION

Ph.D. in Pharmaceutical Sciences (2011), Arnold & Marie Schwartz College of

Pharmacy and Health Sciences, Long Island University, NY

? Ph. D Research: Physical characterization of ethyl cellulose polymer and

polymeric films with different plasticizers. Evaluate the physical

properties of pharmaceutical solids using XRD, DSC, TGA FTIR, SEM and DMA

techniques. Long Island University 2011

? Post doc. research involved synthesis and characterization of new silicon

based hybrid inorganic/organic polymer at William Paterson University,

Wayne NJ (2010-2011)

M.S in Chemistry (1991) Department of Chemistry, University of Dhaka

B.S in Chemistry (1989) Department of Chemistry, University of Dhaka

TECHNICAL/ INSTRUMENTALSKILL

Hands-on experience in HPLC and GC techniques. Perform Identification test

by FTIR, NMR and TLC. Worked with UPLC, LC-MS, GC-MS and GPC instrument.

Characterize pharmaceutical ingredients using Particle size analyzer, XRD,

Rheology, DSC, TGA, SEM, DMA and Microscope. Chromatographic Software:

Millennium, Empower, Turbochrom, Totalchrom and Chemstation. Skills on

LIMS, Electronic Lab Note book and Track wise data management system.

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