Ref. No. : CA - 11293 - (Quality – with 17.1 years in Plastic Industry)

Education

Master of Science (Organic Chemistry) from S.R.T.M.U. Nanded, with First Class in 2007

Skill Sets

Computer Skills: Completed course in Web technology curriculum (WTC) and adept at MS Office

Work Experience

Q.A. Officer
Since April 2011
Company Profile: Manufacturer and Exporter of Packaging and Containers.
Job Profile:
Documentation in quality assurance (QMS)
Make SOPs as per pharma guidelines.
Make COA, specification report.
To work all related to IPQA and Q.A. documentation.
Worked on CAPA.
Knowledge of change control, qualification.
To follow the guideline as ISO 9001-2008 industry.

Q.C. Officer
From Apr 2010 to Feb 2011
Company Profile: Leading Formulation Drug Industry.
Job Profile:
Stability section. Performing stability study like
Photo stability
Thermal cycling study
Temperature Excursion study.
Kept batches for a stability studies as per ICH guideline
Maintain stability sample pull-out log, Equip.log, etc.
Prepare protocol and trend chart, STF, of new drug product.To
Perform analysis of stability study sample and inprocess
Product as per specification.
Analysis and reporting of stability sample
Report any deviations, non-conformities, out of specifications results and arising out of any of the activities performed to manager Q.C
Finished product section
Analysis and Reporting of Finished Products (Tablet, Capsule, Injection etc)
Report any deviations, non-conformities, out of specifications results arising out of any of the activities performed to manager Q.C
Validation
Cleaning validation
Analysis and Reporting of Cleaning validation sample.
Report any deviations, non-conformities, results arising out of any of the activities performed to manager Q.C
Process validation
Analysis and Reporting of Process validation sample.
Report any deviations, non-conformities, results arising out of any of the activities performed to manager Q.C

Q.C. Chemist
From Sept 2009 – Apr 2010
Midas-Care Pharmaceutical Pvt Ltd
Job Profile:
Deft at analysis of bulk product, water by K.F. Assay by titration method and standardization for normality
Involved in Patent search and literature search. Dexterous at formulating drug designs & strategies to meet deadlines & ensured quality.
Adhering to the various quality measures, SOP and functioning as an instrumental member for designing and implementing procedures, control systems to maintain quality standards
Establish and use service level and response time objectives while planning and managing the service-level quality using real-time management skills.
Conducted & analyzed preformulation and compatibility studies.
Strict adherence to statutory compliances & obligations. Pivotal in formulating protocols and ensuring the ICH guidelines are followed
Process optimization & Scale-up trials. Accountable for executing & trouble shooting exhibit batches
Prepared master formula record and technology transfers documents, preparation of development reports as per the regulatory norms for different products.
Troubleshoot any issues occurred during product development. Assisted product validation & revalidation.
Provided required technical documents to the regulatory department.

R & D Chemist
From Aug 2007 – Aug 2009
Pharmaffiliates Analytics & Synthetics Pvt Ltd.
Job Profile:
Job responsibilities include Synthesis of API, Intermediates and drugs Impurity
Tramadol hydrochloride, Synthesis of Fusidic Acid Impurities, 6-Methoxy-2-napthaldehyde, Iopamadol, Iohexol.
Monitored the reactions, Synthesizing of intermediates, Apis, and drugs impurities by using varies parameters such as Temperature, PH adjustment and TLC checking.
Used solvents, reagents & catalysts in synthesis reaction as well as hands on experience in distillation
Conversant with Oxidation, reduction, nitration, sulphonation, and dehydration as well as performed Halogenations and dehalogenation reactions.
Used column chromatography system for purification and mixture separation.

Future Goals

To be a Well Experienced in Quality Field of the Industry


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