Quality Assurance Development

Rekharani Bhashyam

Tel No: 732-***-****

Email:*********@*****.***

PROFESSIONAL SUMMARY:

Competent and hardworking Analytical Scientist with over 13 years of pharmaceutical experience in R&D and QC

environment. Excellent knowledge of cGMP, efficient team player and able to complete assignments

independently with excellent documentation skills. Excellent experience in writing and reviewing analytical

documents such as methods, protocols and validation reports. In-depth knowledge and hands-on experience in

routine and specialized analytical techniques. Strong problem-solving and troubleshooting skills. Excellent

communication, interpersonal and organizational skills. Proven record of completing projects on time despite very

aggressive time lines.

PROFESSIONAL EXPERIENCE:

Scientist

Novartis Pharmaceuticals, East Hanover, NJ Oct2008- Present

• Coordinated activities in analytical development to support clinical drug product development programs

from early phase to registration.

• Cross collaborate with internal function units (Quality Assurance, Chemical Development,

Pharmaceutical Development) for phase appropriate development planning to ensure appropriate

analytical support.

• Performed method development and validation activities to ensure method accuracy and reliability for

various types of drug products like solid oral dosage forms for assay and degradation products utilizing

techniques such as HPLC, GC, UV, dissolution including automation, KF testing etc. as per

USP/ICH/FDA guidelines.

• Volunteered in writing CMC p2 module. And volunteered for data integrity check for all the source

documents of CTD modules for submission.

• Implemented Quality-by-Design (QbD) and Design of experiments (DOE) approaches to HPLC method

development. Also, applied and utilized QbD including FMEA (Failure mode and Effect Analysis)

approach to method development and method validation activities

• Performed method transfer studies to transfer methods to other sites, and compiled the data into method

transfer reports.

• Routinely supported analytical testing needs of other team members to address resource shortages and to

meet tight project timelines

• Performed release and stability testing of samples from technical, clinical, and registration batches and

authored analytical documents in TEDI (Technical Data Information Systems) for review.

• Perform analytical activities for PPA (Post packaging analysis) for clinical batches and on-going clinical

studies.

• Document and review notebooks, write technical documents (protocols, reports and test methods, etc.) in

compliance with cGMP regulations.

• Trained junior associates on analytical equipment, methods and internal processes. Assigned day to day

work activities and monitored timely completion and quality of deliverables

• As a laboratory safety committee core member to support the company's objective of no time lost for

accidents, Lead lab safety inspection audits to maintain a safe lab environment.

• Used AQWA systems for documentation of lab investigations, and deviations .

• Excellent knowledge of cGMPs, GLPs and excellent documentation skills.

• Excellent communication and leadership skills.

• Housekeeping, labs according to cGMP standards and requirements.

Senior Research Chemist

West Ward Pharmaceuticals (Generic), Eatontown, NJ Jan2006- Oct2008

• Performed method development and validation of analytical methods as per USP/ICH guidelines; write

method validation reports for validated methods for ANDA/NDA/OTC products.

• Tested raw materials, in process, final product, stability and R & D

samples by USP and in house methods.

• Reviewed analytical reports for ANDA/NDA submissions to FDA for product approvals.

• Responsible for method transfer studies for solid dosage forms (tablets, and capsules) to quality

control department. Also involved in stability testing of pharmaceutical products, perform dissolutions

to support product development.

• Trained entry level / junior chemists in instrumental techniques used in analytical work.

• Wrote and reviewed analytical test methods, validation protocols and validation reports.

• Optimized existing methods to achieve increased robustness and efficiency of test methodologies.

• Utilized techniques such as HPLC, UPLC and GC (Waters- Empower2).

• Trained laboratory personnel on laboratory safety being a laboratory safety committee member.

• Reviewed junior chemists note books.

Research Chemist

Sandoz Pharmaceuticals (Generic Division of Novartis), Dayton, NJ Jan2003-Nov2005

• Responsible for the development of various analytical methods for solid and liquid dosages and Drug

Products.

• Represent the data, manage the stability studies and discuss progress reports with group leader.

• Worked on the projects that involved from basic raw material to the finished product testing.

• Proficient with analytical instruments such as HPLC, GC, TLC, AAS, FTIR, UV- VIS

and KF titration and wet chemistry for solid dosages drug products.

• Experience of tablet dissolution, disintegration, hardness and friability testing of drug products.

• Knowledge of cGMP, GLP, OSHA and FDA regulations and USP/NF/BP/EP compliance for solid

dosage drugs.

• Responsible for the training of Jr. Chemist and training record keeping for cGMP purposes.

• Utilize techniques such as HPLC (Waters- Millennium 32 Software, Hewlett Packard, and Shimadzu

along with Totalchrom), UV (HP Chemstation), and IR spectrophotometry.

• Trained laboratory personnel on laboratory safety.

• Reviewed the notebooks of junior chemists.

Supervisor (Organic Department)

Townley Labs, Plainfield, New Jersey. Jan 1993 -Jan 2000

• Nine years of experience in research and development laboratory as a Supervisor, Group

Leader and Chemist, with focus on Qualitative and Quantitative analysis of soil, water and all organic and

inorganic type of samples, using GCMS, GC and AA techniques.

• Worked on various aspects of EPA methods, SOP’S.

• Strong research, documentation and report writing skills.

• Ability to train and supervise other Chemists and Lab technicians.

• Proven interpersonal relations, and people skills.

• Familiar with all Emergency Response, OSHA, MSDS and right to know/Hazardous

Communications regulations.

EDUCTION:

M.S. in Biology Andhra University India

B.S. in Science St. Joseph’s College India

Associate Degree in Computer Information Systems DeVry College Of Technology, US

TRAINING:

Planum Scientific Research, Inc. Hackensack, New Jersey.

• Received training with analytical instruments such as HPLC, GC, TLC, AAS, FTIR, UV-VIS and KF

titration and wet chemistry for solid dosages drug products emphasizing troubleshooting.

• Also obtained training in dissolution, disintegration, hardness and friability testing of drug products.

ADDITIONAL SKILLS:

• Proficient with HPLC, Dissolution (Manual and automated).

• Data acquisition systems: Waters Millennium 32 and Empower, Turbochrom, Totalchrom,

HP Chemstation, Chromeleon from Dionex and LIMS

• Microsoft office.

• Team player, possess good communication skills, hard working and can work under pressure.

• A member of the health and safety team.

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