KINJAL THAKAR

Mobile: +918*********

Email: adn8uk@r.postjobfree.com

OBJECTIVE

Aspiring for assignment in Microbiology Section/Quality Control/Quality Assurance in a leading life science and pharmaceutical organization.

EXPERIENCE

Associated with Sun Pharmaceuticals Industries Limited, Panoli as Senior Officer in Microbiology Section since September-2015 till present.

ABRIDGEMENT

• A dynamic professional with more than 6 years of experience in Microbiology Section.

• Faced various Regulatory Audits like USFDA, EDQM, TGA, RUSSIA, UKRAINE, WHO-GMP and Customer Audits.

• Proficient in various Microbiology Testing like Purified Water, WFI, BET and MLT.

• Hands on experience for various validations like Water System, Finished Product, BET, MLT, Disinfectant Efficacy.

• Environmental Monitoring which includes Clean Room for Plate Exposure, Air-Sampling and Contact Plates Area Qualification and Personnel Monitoring.

• Protocol & Report Preparation for various Microbiological Testing.

• Culture Management as per cGMP Requirement.

• Morphology of microorganism derived from various samples like Water, EM and Finished Products.

• Autoclave and Incubator Qualifications as per cGMP.

• Flora Management as per cGMP Requirement.

• Following of Aseptic techniques as per cGMP.

CORE COMPETENCIES

VALIDATION

QUALIFICATION

DOCUMENTATION

AUDIT & COMPLIANCE

• Analytical and technical hand in microbiology

• Experience to work with LIMS 4.1.2, D2, EDMS, LMS

• Successfully faced USFDA Audits, EU Audits, WHO Audits, TGA and other customers and Regulatory Audits

• Follow SOPs to perform methods requiring precise analytical skills and understandings.

• Demonstrated flexibility in responding to unexpected demands

• Prioritize assigned work to minimize time and equipment efficiency

• Build strong synergetic relationships within a team environment to ensure the team’s performance is optimized and department goals are achieved.

JOB PROFILE

• MLT of Finish products, stability products and Bio burden

• MLT validation and BET validation study

• BET, Primary packaging material analysis and Swab testing

• Sampling and complete (microbial & chemical) analysis of purified water, process water, water for injection and pure steam as well as water System validation

• Media preparation, sterilization, incubation, reconciliation, disposal, and growth promotion test

• Environmental monitoring and daily monitoring of area

• TOC analyzer, Micropipettes, balance, pH meter and conductivity meter operation and calibrations

• In-house culture preparation and Bio ball qualification, identification, and verification

• Auto clave and steam sterilizer qualification

• LIMS registration and reporting

• Protocol preparation and validation study

• Monthly and Yearly trend preparation

INSTUMENTAL EXPOSURE

• Total organic carbon analyser (TOC-L Shimadzu)

• Laminar Air Flow (Airpac)

• Colony Counter (Lapiz)

• Autoclave Equitron (Medica-praano)

• Analytical and palm top balance (Mettler Toledo)

• pH and Conductivity meter (Mettler Toledo)

• Steam sterilizer (Metal chem)

• Laboratory incubators, Deep freezer, and cooling chambers (ICDAS-Newtronic Software)

• Heating block (Neolab)

• Air sampler

• Drying Oven (thermo lab)

• Filtration assembly (Pall corporation)

ACADEMIC PROFILE

• Completed M.Sc. Biochemistry from Sardar Patel University in April 2015 with 8.12 CGPA (Gold Medalist)

• Completed B.Sc. Biochemistry from Sardar Patel University in April 2013 with 6.76 CGPA. PROJECTS

• Purified Water System validation of more than 9 Nos. of plants

• Media Hold Time Study (Extended from 07 to 15 days)

• Study of disinfectant efficiency on different surfaces.

• Protocol preparation and method validation study on MLT and BET validation of more than 15 products.

• Dissertation work done on MTHFR gene polymorphism as risk factor for development of under nutrition.

• Poster presentation on Catalase gene polymorphism in cataract patients, in National conference titled

“Latest developments in basic and applied sciences” organized by M.B. Patel science college, Anand held on 10 January 2015.

• February 2013: Participated at Science Manthan-2013, organized by P.D. Patel Institute of Applied Sciences, CHARUSAT, Changa.

PERSONAL DETAILS

Date of Birth:24th May 1993

Languages Known: English, Hindi & Gujarati

Permanent Address: 101-Antara, Avdhoot Flats, B/h New Era School, Nizampura, Vadodara -390002, Gujarat (India).

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