Himali Ajaykumar Shah

adyu4f@r.postjobfree.com

Mobile Number: 905-***-****

**** *** **** ********, ***********, ON L5M5J7

OBJECTIVE

Over 4+ years of experience as a quality Control specialist, I am a goal-oriented professional. To ensure product quality and safety, I'm looking for a quality control/ Quality assurance position with a manufacturing firm.

PROFESSIONAL EXPERIENCE

Laboratory Technician

Nov 2021 to May 2023.

Bureau veritas, Mississauga, Ontario.

Followed cGMP, GDP, and SOPs to ensure compliance with quality control and safety standards.

Conducted biological and chemical contaminant analysis on raw materials, intermediate, and finished samples using SOPs and other protocols.

Managed daily workloads and ensured client TAT requirements were met by reviewing LIMS summary reports.

Calibrated, operated, and preventive maintained laboratory equipment, including pH meters, plate pourers, weighing machines, Biosafety cabinets, autoclaves, Master claves.

Prepared media and stock solutions for sample testing, performed microbiological tests, environment monitoring and quality checks.

Troubleshot and maintained laboratory equipment to ensure reliability and accuracy.

Excellent in entering data, identifying trends, and producing EM trend reports.

Focused on maintaining regulated paperwork, accurately recording information, and reviewing logbooks in detail.

Managed laboratory stocks and supplies to ensure efficient and uninterrupted operations.

Quality Control Officer

June 2016 - July 2019

Sahajanand Medical Technologies, Sachin, India

Managed and conducted numerous microbiological activities, ensuring proper sanitation and laboratory analysis on all items. Tested component samples for contamination, analyzed the source of any detected contamination, and took corrective action, participated in internal audits.

Conducted microbe cultures in isolation according to standard inhibitors and maintained proper moisture and temperature conditions.

Developed testing procedures for raw materials and equipment and maintained records of all incoming components and finished goods.

Monitored laboratory samples for GMP violations, maintained accurate records, and conducted tests on all laboratory activities.

Efficient at handling CAPAs, deviations, and change controls while ensuring quality standards are followed.

Experienced in aseptic procedures, microbiological detection, and environmental monitoring for quality control.

Conducted water sampling, air sampling, raw material testing, plate pours, plate inspections, and microscopic examination.

Performed media preparation, Gram staining, Microbial limit test (MLT), Bioburden test, Total bacterial count test (TLC), and Bacterial endotoxin test (BET/LAL test). Proficient in Autoclave, Incubator, Hot Air Oven, and Laminar Air Flow.

EDUCATION

Chemical Laboratory Technician

Sept 2019 - Apr 2021

Durham College, Oshawa, ON

Bachelors in biotechnology (Canadian Equivalency)

Apr 2012 – May 2016

Shree Ram Krishna institute of Science and Technologies, Surat, India

PROFESSIONAL SKILLS

Knowledge of Critical Control Points (CCP), Hazard Analysis and Critical Control Points (HACCP), First in First Out (FIFO), Safety Data Sheets (SDS), Quality Management systems (QMS), Corrective actions and preventive actions (CAPA) International Organization for Standardization (ISO), Health Canada and FDA and Safe Quality Food (SQF) concepts.

Authored Laboratory Manuals and review, revise and update Standard Operating Procedures (SOPs) to improve laboratory efficiency and quality control measures.

Possess excellent analytical and titration skills.

Experienced with various laboratory equipment and techniques such as pipetting, including metal detectors, colorimetry, HPLC, GC, IR, PCR, and UV spectrophotometers. Capable of handling, calibrating, validating, and maintaining the equipment.

Proficient in MS Word and MS Excel, outlook for data analysis, report writing, and documentation management.

Ability to work in fast paced environment, Problem solving, Communication skill, decision making skill, teamwork.

REASERCH PROJECT

Quality Control Test of Pharmaceutical Drug

Jan 2016 – Apr 2016

Zota Pharmaceutical PVT LTD, Surat, India

Proficient in various pharmacopoeias including EP, USP and IP.

Experienced in conducting quality control tests and analyzing results.

Skilled in performing chemical and microbiological testing on raw materials, in-process products, and finished drugs.

Expertise in calibrating and validating pharmaceutical machinery.

CERTIFICATES

Certified in Laboratory Safety

Certified in Quality Control test of Drug.

Certified in WHIMS

REFERENCES

Professional references are available upon request.

Contact this candidate