Ushmaleena Basumatary
Singapore
Summary
Proficient Pharma individual with 4 years' experience in Medical Device Regulation, inspection checks, regulatory reviewer combined with experience as a Quality Analyst along with expertise in academic research. I am looking out for job opportunities in Singapore where I can enhance my experience and contribute earnestly in healthcare sector.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Assistant Drugs Inspector
Central Drugs Standard Control Organization
09.2014 - 07.2018
- Regulatory Officer actively responsible for reviewing applications for Registration and Import of Medical Devices from countries worldwide having approvals from Notified regulatory bodies like United States Food and Drug Administration (USFDA), Medicine and Healthcare Products Regulatory Agency (MHRA), Health Canada, Therapeutic Goods Administration Australia (TGA), Pharmaceutical and Medical Device Agency (PMDA).
- Got an insight of the Pharmacy and medical Device sector by attaining various conferences and workshops like AHWP.
- Responsible for creative design for New Medical device Website logo.
- Assisted Senior Regulatory Officials with document organization, power point presentation and dissemination during workshops, meetings.
- Supported Drug Controller General Of India with daily operational functions.
Quality Control Analyst
Mylan Laboratories Pvt. Ltd
07.2013 - 04.2014
- Responsible to analyze day to day samples of raw materials/ packaging material/ in process/ finished products/ stability/ validation samples as per specifications.
- Execute analytical method transfers, Conduct laboratory instruments calibrations, Conduct Preventive maintenance program for laboratory instruments.
- Maintained compliance with safety and clean area procedures.
- Participated in resolution of laboratory issues / concerns with respect to methods, inter-departmental issues, regulatory, market complaints.
- Review and follow on-line documentation practices.
- Participate in internal audits as well as external audits like USFDA, MHRA, CDSCO
- Determined proper corrective actions to bring products in line with requirements.
Education
Master in Pharmacy - Pharmaceutics
Banaras Hindu University
Varanasi, UP2013
Bachelor of Pharmacy - Pharmaceutical Sciences
Girijananda Chowdhury Institute of Pharmaceutical Science (GIPS)
Guwahati, AS2011
Registered Pharmacist - Pharmacy
Assam Pharmacy Council
Guwahati, AS2012
Skills
- Inspection
- ISO 13485
- Regulatory
- Analytical Method Development
- Research
- LIMS, HPLC, Validation, Assay
- Microsoft Office- PowerPoint, Excel, Word,Publication
- Documentation
- GLP, GMP
Accomplishments
- Qualified Graduate Pharmacy Aptitude Test (GPAT), securing AIR 1003, year 2011
- Participated in Healthcare Innovation World Cup, year 2013, organized by Boehringer Ingelheim and got selected in round 2 among 100 participants for the idea of DiaTreat Pen in tackling Diabetes.
Additional Information
Awarded ANUNDORAM BOROOAH AWARD in recognition of excellent academic performance in securing First division with star marks in High School Leaving Certificate examination, 2005, conferred by Chief minister of Assam.
Certification
- Successfully completed hands-on training as directed by CDSCO at Regional Drugs Testing Laboratory, Guwahati on Good laboratory practices using chemical, instrumental and microbiological methods from 19.06.2017 to 01.09.2017.
- Induction Programme for Assistant Drugs Inspectors of CDSCO organized by Central Drug Standard Control organization from 8th March 2017 to 4th June 2017 at National Institute of Biologicals, Noida.
- Certified for participating in training of SUGAM Portal, iConnect & Basis of MS Office conducted by C-DAC, Noida under induction training programme of Assistant Drugs Inspector of CDSCO of Ministry of Health & Family welfare, Govt. of India.
- Workshop for Drugs Regulators on Medical Devices, organized by CDSCO, Govt. Of. India at Gujarat Forensic Sciences on Medical Device, Year 2015.
- Certified in Entrepreneurship Development/Skill Development Programme conducted by M.S.M.E Development Institute, Ministry of Micro, Small, Medium Enterprise, Govt. of India, Year 2011.
Publication
Published a paper with the title Corrected Absorbance Method for the Simultaneous Determination of Rifampicin, Pyrazinamide and Isoniazide in Bulk and Pharmaceutical Dosage Forms in International Journal of Advances in Pharmacology and Toxicology.
References
Dr. S Eswara Reddy (DCGI), Drugs Controller General of India
CDSCO, Ministry of Health and Family Welfare, Government of India, New Delhi, India
Contact: dci@nic.in
Relationship: Superior
Timeline
Assistant Drugs Inspector
Central Drugs Standard Control Organization
09.2014 - 07.2018
Quality Control Analyst
Mylan Laboratories Pvt. Ltd
07.2013 - 04.2014
Master in Pharmacy - Pharmaceutics
Banaras Hindu University
Bachelor of Pharmacy - Pharmaceutical Sciences
Girijananda Chowdhury Institute of Pharmaceutical Science (GIPS)
Registered Pharmacist - Pharmacy
Assam Pharmacy Council
- Successfully completed hands-on training as directed by CDSCO at Regional Drugs Testing Laboratory, Guwahati on Good laboratory practices using chemical, instrumental and microbiological methods from 19.06.2017 to 01.09.2017.
- Induction Programme for Assistant Drugs Inspectors of CDSCO organized by Central Drug Standard Control organization from 8th March 2017 to 4th June 2017 at National Institute of Biologicals, Noida.
- Certified for participating in training of SUGAM Portal, iConnect & Basis of MS Office conducted by C-DAC, Noida under induction training programme of Assistant Drugs Inspector of CDSCO of Ministry of Health & Family welfare, Govt. of India.
- Workshop for Drugs Regulators on Medical Devices, organized by CDSCO, Govt. Of. India at Gujarat Forensic Sciences on Medical Device, Year 2015.
- Certified in Entrepreneurship Development/Skill Development Programme conducted by M.S.M.E Development Institute, Ministry of Micro, Small, Medium Enterprise, Govt. of India, Year 2011.
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