Senior Executive with 4+ years in Quality assurance handling various activities like Quality management systems, Audits, Validation of equipment's, In-process quality control activities in various Multi-national companies.
Actively seeking full-time opportunities in Quality Assurance and Regulatory Affairs starting from December 2016.
Presented two posters in Indo American Pharmaceutical Regulatory Symposium, in the year 2010 held at SRMC, Chennai by Northeastern University Boston, with the titles "Trade Mark Laws in India- An overview" and "An overview of Australian Pharmaceutical Regulatory Body".
MASTER OF PHARMACY THESIS
Pharmaceutical Quality and Risk Assessment: A case study on Anti-cancer drugs by using ICH (Q9) Risk Assessment Tools at Natco - Pharma Ltd. Kothur, 509228.
Senior Executive08/2014 to 06/2015 BIOCON LIMITED – ELECTRONIC CITY BENGALORE INDIA
Biocon is one of the largest biotech company in Asia.
Leading suppliers of insulin and Anti-cancer drugs.
Handled the Quality Management system(QMS) Change control management: Evaluation, approval and scientific disposition of changes with impact assessment from quality and regulatory prospective.
Conducting investigations to identify the possible root cause for any deviations from written procedures, assessing the impact of deviation and Identifying Corrective and Preventive actions to prevent recurrence and occurrence of the deviation.
Conduction internal audits and External Vendor Audits.
Participating for customer complaint & technical inquiries.
Support to Regulatory department by providing required data for regulatory and customer audits.
Aseptic process simulation study protocol and report preparation.
Participated in qualification of areas, instrument, equipment's.
Certified internal Auditor of the company.
Part of audit team and faced Audits like MHRA, PMDA, COFEPRIS, ANVISA.
Preparation of audit responses, reports and necessary follow-ups on the implementation of corrective and preventive actions within the identified timelines.
Expertise in Preparation of high level documents and protocols like Batch manufacturing records, SOPs, Process Validation, Cleaning validation and Hold time studies (DEHT, CEHT & SHT).
Senior officer08/2013 to 08/2014 RANBAXY Laboratories Limited – BENGALORE INDIA
Ranbaxy is the part of Sun pharma group which is one of the largest pharma MNC in the world and has operations over 43 counties and 21 manufacturing facilities with 500 molecules in portfolio.
Preparation of SOPs, Issuance, distribution, Reviewing and controlling GMP Documentation.
Performing Risk assessment studies for the processes and systems and preparing plans for mitigating risks with high severity by using Risk management tools like FTA, FMEA (ICH Q9).
Handling all the In-process quality Assurance activities in sterile manufacturing facility.
Reviewing all the GMP documents.
Faced FDA audits.
Part of Internal audit team and conducted External vendor audit (FAT).
Handled Installation Qualification IQ, Operational Qualification OQ, Performance Qualification PQ, Requalification RQ of Various key equipment of production.
QA Executive05/2012 to 07/2013 BIOLOGICAL E – Hyderabad, India
BE is the first private sector biological company in India and first pharmaceutical company in south India.
BE supplies several essential lifesaving vaccines and pharmaceutical to UN agencies via., UNICEF.
Performing in process checks (IPQA) at Dispensing, formulation, filling, sealing and visual inspection and ensuring that the Good manufacturing activities are followed.
Reviewing of all the documents related to production (BMR, BPR), QC (LCR, Specifications), Engineering (Maintains schedules) as per Good documentation practices(GDP).
Final bulk batch release.
Successfully faced WHO Audit, CDSCO Audit for Anti Snake Venom.
Execution of validation activities like performing Re-qualifications (RQ), Preparation of protocols and also execution of the validation activities of Autoclaves, Incubators, Cold rooms, Fermenter, Deep freezers, water baths and final report preparation.
QA Chemist11/2008 to 05/2010 TRIVENI FORMULATIONS – VIJAYAWADA AP INDIA
Performing in process checks (IPQA) at Dispensing, formulation, filling, selling and visual inspection and ensuring that the Good manufacturing activities are followed.
Reviewing of all the Batch manufacturing records and various other GMP related documents.
Master of Science: QUALITY ASSURANCE AND REGULATORY AFFAIRSCurrentTEMPLE UNIVERSITY-
Master of Science: QUALITY ASSURANCEMay 2012JSS UNIVERSITY-
Bachelor of Science: PHARMACYOctober 2008RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES-
BENGALORE KARNATAKA INDIA3.37