Summary
Overview
Work History
Education
Languages
Additional Information
Timeline
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Manisha Devi

La Prairie,QC

Summary

Highly skilled individual with over four years of experience in microbiological testing, environmental monitoring, and compliance with GMP standards. Proficient in technical writing, laboratory investigations, and continuous improvement projects. Well versed to operate to a high standard and comply with cGMP and other appropriate regulatory standards.

Overview

5
5
years of professional experience

Work History

Associate Scientist

GLAXOSMITHKLINE
09.2022 - 03.2023
  • Assisted in technical writing, including standard operating procedures.
  • Supported all aspects of laboratory investigations.
  • Contributed to decommissioning activities, ensuring equipment was safely retired.

Brand Ambassador

WDS
10.2022 - 02.2023
  • Comply with Health and Safety Act 1974, food safety laws and guidelines
  • Increased positive word-of-mouth referrals through genuine, personalized customer interactions and excellent product knowledge.
  • Ensured accurate representation of the brand by maintaining consistent messaging and visuals across all promotional materials and presentations.
  • Enhanced brand recognition by executing promotional events and engaging customers with product demonstrations.
  • Boosted sales through effective collaboration with store staff to promote products in high-traffic areas.

QC Technician - Microbiology and Environmental Monitoring

CELL AND GENE THERAPY CATAPULT
09.2019 - 08.2022
  • Trained staff in Environmental Monitoring, participating in 4 OQs, and 5 PQs of cleanrooms.
  • Devised rationales and created maps for new EM locations.
  • Issued notifications of EM excursions, ensuring prompt action.
  • Involved in data transcription of EM data for trending purposes, maintaining an accuracy rate of 99%.
  • Contributed to customer satisfaction by promptly addressing quality-related issues, resolving complaints, and providing technical support as needed.
  • Acted as Subject Matter Expert and Trainer for material release, reviewing and updating raw material specifications.
  • Participated in deviation/non-conformance management events to complaint conclusions, and performing effectiveness checks post CAPA implementation.
  • Reviewed and revised SOPs and documentation, enhancing compliance.
  • Assisted in the qualification of walk-in incubators and supported the validation of fridges/freezers.
  • Managed routine biohazard waste removal and inventory (KANBAN)
  • Created schedules for the team, and managing changes effectively.
  • Assisted in achieving company objectives by providing accurate and timely data analysis for continuous improvement efforts.
  • Engaged in continuous improvement/OpEx projects, conducting process audits.
  • Supported QC sample management and plate reading (trainer), providing a timely and efficient service for collaborators.
  • Utilized BacT/Alert 3D Microbial Detection Systems and dataloggers for temperature monitoring.
  • Initiated and performed Phase 1 a/b investigations.
  • Conducted speciation assessments, liaising with qualified external laboratories for time sensitive ID reports.
  • Maintained a safe work environment by adhering to established safety protocols, reporting potential hazards, and participating in safety trainings.

Microbiology Officer

BRISTOL LABORATORIES
02.2019 - 08.2019
  • Monitored non-sterile manufacturing and packaging areas.
  • Collected samples for analysis, ensuring quality control.
  • Conducted pathogen testing and growth promotion testing of media from external suppliers.
  • Reviewed documentation and revised general test procedures, maintaining compliance.
  • Maintained strict adherence to industry regulations, minimizing risk exposure for the organization.
  • Assisted in testing raw materials, in process samples, and finished products.
  • Aligned new staff on identification and basic microbiology techniques.
  • Utilized biosafety cabinets, laminar airflows, and incubators.
  • Conducted water sampling and testing (membrane filtration).
  • Acted as Health and safety representative of microbiology department.

QA Scientist Micro

GLAXOSMITHKLINE
07.2018 - 01.2019
  • Conducted environmental monitoring using active air, contact plate, and swab methods.
  • Aseptically collected water samples from laboratory and pilot plant.
  • Performed water testing (membrane filtration) and analyzed samples.
  • Proficiently used LIMS for batch creation/completion of EM batches.
  • Conducted microbial identification of environmental and water isolates.
  • Used an automatic Gram stainer for efficient sample processing.
  • Demonstrated strong scientific writing, documentation practice (ALCOA), and archived documents.
  • Maintained excellent housekeeping, stock control, and laboratory practices.
  • Planned day-to-day activities in a team-driven environment.

Education

GoLeanSixSigma | Green Belt -

04.2022

Bachelor of Science (Hons) in Biomedical Science (Pass) -

Middlesex University
05.2019

BTEC Applied Science (Distinction) -

Luton Sixth Form College
06.2015

A Level Use of Mathematics (Pass) -

Luton Sixth Form College
06.2015

GCSE French (Distinction) -

Icknield Highschool
05.2012

Languages

English
Native or Bilingual
French
Professional Working

Additional Information

Language Skills: Active French learner, enrolled in Quebec French course to enhance communication and integration into the Montréal workforce

Work Permit: Valid work permit for Canada

Driving: Full UK driver's license (eligible to exchange)

Timeline

Brand Ambassador

WDS
10.2022 - 02.2023

Associate Scientist

GLAXOSMITHKLINE
09.2022 - 03.2023

QC Technician - Microbiology and Environmental Monitoring

CELL AND GENE THERAPY CATAPULT
09.2019 - 08.2022

Microbiology Officer

BRISTOL LABORATORIES
02.2019 - 08.2019

QA Scientist Micro

GLAXOSMITHKLINE
07.2018 - 01.2019

GoLeanSixSigma | Green Belt -

Bachelor of Science (Hons) in Biomedical Science (Pass) -

Middlesex University

BTEC Applied Science (Distinction) -

Luton Sixth Form College

A Level Use of Mathematics (Pass) -

Luton Sixth Form College

GCSE French (Distinction) -

Icknield Highschool

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Manisha Devi