Quality Control Medical Device

Rasika Hariprasad Alwe

Summary:

Rasika has * yrs. of experience in Pharmaceutical and Laboratory testing industry.

Experienced as Quality Control professional (Laboratory) in Pharmaceutical/ Medical device industry where utilized practical experience and technical skills.

Worked in Quality Control Department as a Quality Control Analyst in Intertek India Pvt. Ltd. and Cipla Ltd.

Completed QA Manual testing training.

Analysed pharmaceutical, food and agricultural Products in accordance with the company specifications.

Organized and reviewed data in sample testing books and chemical control logbooks.

Supervised and provided leadership for three laboratory technicians.

Investigated new methods under the guidance of senior analyst or supervisor.

Documented and kept log of daily Quality Control duties as required by company’s policy.

Assisted in maintaining laboratory equipment, supplies and facilities.

Skills:

UV-Visible Spectrophotometer (Shimadzu).

High Performance Liquid Chromatography (HPLC) (Shimadzu).

Karl-Fischer Coulometer.

Fourier Transform-Infrared Spectrophotometer (FTIR) (Perkin-Elmer).

Sophisticated analytical instruments.

Technical:

MS Word, MS Excel and MS Power Point.

Education:

Bachelors of Science (Chemistry), University of Mumbai, IND, 2007.

Secondary School, Kolhapur Board, IND, 2004.

Experience:

QC department, Intertek India Pvt. Ltd., Mumbai, IND Apr 10 – Nov 14

Quality Control Chemist (Laboratory)

Responsibilities:

Analysed pharmaceutical, food and agricultural Products in accordance with the company specifications.

Operated and Calibrated instruments like UV-Visible spectrophotometer, FTIR, Dissolution Tester, various weighing and measuring equipment’s.

Organized and reviewed data in sample testing books and chemical control logbooks.

Supervised and provided leadership for three laboratory technicians.

Followed standard operating procedures and experimental guidelines to ensure products complied with established specifications.

Completed all regulatory and job training requirements including safety, compliance, specific testing etc.

Demonstrated ability to improve upon current laboratory practices through ability to learn new skills, procedures, and processes.

Cipla Ltd. (Aerosol department), Goa, IND Feb 08 – Mar 10

Quality Control Analyst

Responsibilities:

Conducted analytical tests on samples of Finished products in accordance with the company and USP specifications.

Prepared Sample and Standard also prepared Mobile Phase and Media as per test.

Investigated new methods under the guidance of senior analyst or supervisor.

Documented and kept log of daily Quality Control duties as required by company’s policy.

Examples of tests performed: LOD, Residue on ignition, Heavy Metals, Particle Size, etc.

Reporting and Reviewing of Analytical reports.

Assisted in maintaining laboratory equipment, supplies and facilities.

Prepared and conducted internal and external audits and helped prepared for a regulatory inspection.

Followed company SOP’s in day- to- day activities, also maintained cGLP compliance.

Other Experience:

Volunteer at ECFE children’s program at Crossroads Elementary Saint Paul.

Volunteer at Festival of Nations at the Culture Booth and Food Stall answering people about Indian culture and its Heritage.

Volunteered to cook and serve food at the temples to raise funds for donation.

Volunteer at CTC commonwealth terrace community gathering function.

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