Purushotthama Rao. Kothapalli

Long Island, NY-***04

adx3a3@r.postjobfree.com

267-***-****

Objective:

To seek a challenging position that offers opportunity to explore my experience and skills in the area of Quality Control in such organizations which provides a work environment, fosters teamwork and allows independent responsibilities.

Working Experience

Quality control Chemist

Scigen Pharmaceutical Company, Long Island, Jan 2021 to Present

Utilized GC, AAS, HPLC/UPLC, LC/MS, NMR, KF to analyze Raw materials, in-process of various API AND Stability samples and finished goods.

Collected processed, previewed, and reported data using Empower3.

Collaborated with Raw Material and Production Departments to support clinical manufacturing needs and specifications.

Complied with Environmental Health and Safety Requirements.

Ensured that all necessary corrections are executed in accordance with cGMP standards.

Notified department supervisor/manager regarding omissions, incomplete testing results or other irregularities.

Conducted investigations in the areas of method performance and reliability and evaluated proposed changes to compendia or developed methods.

Worked within the laboratory in a team environment; assisted with QC initiatives; actively participated in QC projects and team meetings.

Ensured that all laboratory notebooks, instruments logbooks and documents are complete and in compliance with cGMP regulations and company guidelines.

Performed GC, HPLC and/or Wet chemistry analyses on Raw Material samples.

Coordinate lab training, testing method validation, lab staff training, training documentation to meet ASTM, GLP, and GMP compliance documentation. Spearhead acquisition of new software, and customer correlation studies. Performed LIMS system maintenance (version upgrades, beta testing, and Sequel Server custom modifications) generated custom reports from lab data for Lab methods and batch production SPC, lab operation cost analysis, and alloy/customer specification history.

Chemistry Teacher

R.T. Hudson School, Bronx Aug 2015 To Dec 2020.

Quality control chemist

Hetero laboratories Pvt ltd, Vizag Aug 2011 to Jul 2015.

Job responsibilities:

Responsible for analysis of In-process, Finished products and Stability samples.

Instruments Calibration.

Maintenance of Stability Chambers.

Charging and Withdrawing of Stability Samples as per stability protocol.

Maintaining Newtronics Data (Temperature and Humidity Data Records).

Maintaining documents as per cGMP requirement.

Maintenance of Cleanliness in the working area.

Report review & updating analytical results in stability summaries.

Working and implementing GLP standards in the laboratory.

Responsible for Calibration of instruments and documentation.

Preparation of SOPs and STPs .

Responsible for Maintenance of HPLC Columns’ Records and indenting New columns.

Preparation of COA and Stability compilation Reports.

Review of Analytical report and submission of data.

Initiating of OOT/OOS as per SOP.

Investigation of OOS/OOT and Closing as per SOP.

Communicating with customers.

Daily Work allotment to team members and monitoring.

Initiating Deviations / CAPA and closing.

Conducting Training sessions to respective team members.

Handling of LIMS, QAMS & DMS software’s.

Educational qualification:

M.sc (organic chemistry) - from Osmania university during the period of 2009-2011 with first class.

M.sc (Mathematics) -from acharya Nagarjuna university during the period of 2020-2022 with first class.

B.sc (MPC) - from acharya Nagarjuna university during the period of 2006 – 2009 with first class.

Computer knowledge:

MS-Office. (MS-Word, MS-Excel, MS-Power point)

Internet Basics.

Highlights:

Following cGLP and Laboratory Safety.

Plan, organize, and schedule activities with varying levels of supervision, based on the situation, in support for new product launches, existing marketed products.

Member of Laboratory Safety Squad.

Personal strengths and attributes:

Persistent and thoughtful in undertaking tasks, with structured work habits.

A good team worker as well as target-oriented leader.

Adopt a wide approach towards an issue under consideration.

Contact this candidate