PROFILE

*+ yrs of Experienced Microbiologist in the field of Medical devices and Pharmaceuticals as per Pharmacopeia standards, Indian Medical Device Rules & EU MDR regulations. Proficient in the strategic development and oversight of microbiological testing protocols to product safety and compliance with 21 CFR regulatory standards. Seeking a challenging role that leverage my technical skills and provides opportunities to grow by taking critical responsibilities in an organization with high ethical values. PROFESSIONAL EXPERIENCE

2023 Apr – present

Chennai, TN

Applied Microbiologist

MicroGO LLP

•Microbiological laboratory maintenance in accordance with USP - 1117.

•Examining, culturing and identification of microorganisms.

•Expertise in sampling techniques and conducting comprehensive bacteriological examinations of water and the coliform test as per IS:1622:1981 (R.2009).

•Assisting scientists in handling and performing research projects.

•Ensuring the integrity of laboratory processes by conducting routine quality control assessments on consumables.

•Adhere to protocol or test methods based on standard and interpret results.

•Performing SOP discovery for microbiological laboratory.

•Proficient in generating comprehensive reports and maintaining detailed records and journals to document findings and ensure traceability.

•Assisting to an agricultural project focused on minimizing post-harvest losses and extending the shelf life of various fruits and vegetables. 2021 Aug – 2023 Feb

Chennai, TN

Quality control Technician

Teva Pharmaceuticals Private Limited

•Expertise in Microbial Limit Test and pathogen analysis for Water and finished products of stability samples as per ISO 11737-1, USP - 61, 62 & 1111 and updating results in LIMS.

•Performed culture qualification for received standardized strains (Bioball).

•Assisted in the preparation of media, reagents, and materials required for laboratory testing, ensuring accurate and reliable results.

•Handled the calibration of Micropipette, Water bath, Hot air oven, Automated gram Stainer and Colony counter and updation in trackwise.

•Skilled on calibration methods of pH meter and Weighing balance.

•Performed Growth Promotion Test (GPT) for all incoming medias.

•Conducted validation of both Horizontal and Vertical autoclaves using biological indicators, ensuring proper sterilization procedures. 2019 May –

2021 Aug

Chennai, TN

Executive Microbiology

Eucare Pharmaceuticals Private Limited

•Executed microbial analysis of raw materials, in-process, finished products and packaging materials to ensure product quality and safety. Magthalinasha A

QC-Microbiologist

+91-979******* ad00b7@r.postjobfree.com Chennai-600119 linkedin.com/in/magthalinasha X7407612

•Expertise in executing analytical test methods on Sterility analysis as per ISO 11737-2, USP - 71 for Finished Products and stability samples.

•Maintained purity of microbial cultures, including sub-culturing and standardization of culture suspension. Diligently updated related records.

•Conducted periodic environmental monitoring such as air sampler, settle plate, swab, surface monitoring (contact plate) and personnel monitoring in the manufacturing area and production lines (class 5,7,8) in accordance with ISO 14644, 14698-1 & ISO 8537-7 and updating the records.

•Expertly carried out sterility validation encompassing Bacteriostasis and Fungistasis testing, as well as sterilization validation, in strict accordance with ISO 11137 part 1 and part 2 and updating the related documents.

•Executed Bioburden testing for Validation samples of Dose mapping, dose establishment and dose verification and reporting. TECHNICAL SKILLS

•ISO 13485:2016-Quality Management system.

•Internal Audit Training

•Change Control Management

•Gamma sterilization of industrial products as per ISO 11137-1:2015 (Part 1 & 2).

•Good Documentation Practices

•GLP & GMP

•Laboratory Information Management System (LIMS) & Trend analysis

•Trackwise Harmony

GENERAL SKILLS

Written & Verbal Communication

Problem Solving

Research & Data Analysis

Patience & Adaptability

MS-Office & Google Suite

Decision Making

Attention to detail

EDUCATION

2017 Jun – 2019 Apr

Chennai, India

M.Sc., Applied Microbiology

University of Madras

First Class with 84%

2014 Jun – 2017 Apr

Chennai, India

B.Sc., Microbiology

University of Madras

First Class with 85%

LANGUAGES

Tamil (Native) English (Proficient)

REFERENCE

Available on Request

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