Kishan Mistry
Change Control Coordinator at GBUK Group- Claim this Profile
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Bio
Credentials
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Essentials of European Medical Device Regulations (EU MDR) - 2017/745
AlisonJul, 2022- Nov, 2024
Experience
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GBUK Group
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United Kingdom
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Medical Equipment Manufacturing
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1 - 100 Employee
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Change Control Coordinator
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Jun 2022 - Present
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Abingdon Health plc
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United Kingdom
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Medical Device
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1 - 100 Employee
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Quality Assurance Officer
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Apr 2021 - May 2022
• Heavily involved in York Quality Assurance Operations involving batch review compliance, management of Non-Conformances (NCs) and CAPA investigations. • Proficient in the execution of SMART CAPA investigations whilst also advising departments on their subject related NCs. • Responsible for reviewing and updating quality procedures as part of continuous improvement opportunities. Recently I rewrote and improved our Non-Conformance procedure with a focus on implementation of SMART CAPAs. • I am a self-trained Subject Matter Expert across both York and Doncaster sites in our electronic QMS, Q-Pulse. Due to excellent time management and organisation, I effectively trained 125 people on Q-pulse within a two-week period and created all associated training documentation. • Knowledge of document control through management of our document master list and the distribution of controlled document copies to external customers and suppliers. • Knowledge of Product Change Control through processing internal documentation submissions. • Responsible for the preparation of reports on a weekly basis for senior management and monthly basis for the Quality Management Review. • Involvement in internal auditing with a focus on quality walkarounds to ensure that all labs are adhering to Good Laboratory Practice (GLP). • During previous external audits I have successfully run the backroom which involved collating and providing any documents the lead auditor required. • Responsible for the training of new starters in quality standards (GMP, GDP, GLP) and processes across all departments. Show less
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The HEINEKEN Company
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Netherlands
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Food and Beverage Services
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700 & Above Employee
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Quality Support Analyst
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Apr 2020 - Apr 2021
Duties included: • Frequent work across the Microbiology and Analytical teams carrying out routine testing of beverages. • Membrane filtration and plating onto selective media to assess products for microbiological contamination E.g. Lactics, Pediococci etc. • Routine use of light microscopes on the identification of microbial contaminants from agar plates. • Within the analytical team I frequently tested the Head Retention Value (HRV) of beer samples coupled with NIBEM analysis. • General laboratory housekeeping involving use of autoclaves and media preparation. • Interpreted analytical/micro data received from the Central Laboratory and site Quality Control (QC) Laboratories. Data was presented at site review meetings to production team leaders and managers. • Supported improvement activities with brewing and manufacturing teams to improve the analytical/micro Key Performance Indicators resulting in increased product satisfaction from customers. • Continually coordinated QC Laboratory instrument replacement/repairs and evaluate new instrumentation that will improve analysis techniques. • Provided support on investigative activities relating to product queries and subsequent recommendations on non-conforming product. • Ensured compliance to ISO 17025 standards by adhering to all Quality Management System Procedures, Standard Operating Protocols (SOP) and Policies. Show less
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Fera Science Ltd.
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United Kingdom
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Environmental Services
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300 - 400 Employee
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Assistant Scientist
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Jan 2019 - Apr 2020
Throughout my time at FERA I have had the opportunity to gain breadth of competency approved skills across various teams within the plant protection program that are ISO 17025 and ISO 9001 approved. Within the Virology team I analysed plant and seed samples for symptoms of viral infection before using ELISA for diagnosis. This ranges from viruses such as Tobacco Mosaic Virus (TMV) and Potato Virus Y (PVY) etc. This technique requires both accurate pipetting skills and dilution calculations to ensure success. Daily, I would have to prepare over 40 samples so accuracy and speed were key to smooth and successful testing. My time in the Mycology team has allowed me to develop traditional microscopy skills in the accurate analysis of plant samples for a variety of fungal pathogens and the associated diseases. This can include Phytophthora fragariae, Plasmodiophora brassicae and Phragmidium spp. I prepared samples for analysis via methods such as isolation on growth media, bait tests, damp chambers and light microscopy. The final team involved the examination of plant and seed samples for phytosanitary certification. This consisted of analysing samples for weed seeds or any fungal pathogens such as Cladosporium spp. and Altanatria spp. If weed seeds are detected, they are identified via literature and via crossing checking within a seed collection. The weed seed must not be on a countries specific quarantine list otherwise it's is not allowed entry. I have also been part of the Great Crested Newt (GCN) project which involved testing samples sent in from around the UK for the presence of the Great Crested Newt. I aided in the isolation, extraction and preparation of samples for the detection of GCN DNA via quantitative PCR (qPCR). This project required both speed and accuracy because of the high influx of samples. Show less
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ALS
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Australia
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International Trade and Development
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700 & Above Employee
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Laboratory Technician
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Jul 2018 - Jan 2019
Duties included: • Clearly labelling samples and assisting sample receipt where needed. • Operating laboratory equipment e.g. Autoclave, automated liquid dispensing machines, free steamer and waterbaths. • Completing work without deviation from the documented methodology whilst maintaining high levels of quality control. • Performed daily quality control checks and calibrations. • Production of media and plate pouring with selective agars. • Collected samples from storage locations in preparation for analysis. • Sample preparation and analysis (including accurate weighing and homogenising with selective broths). • Conforming to all site Quality Management Systems and Health and Safety procedures and protocols. This includes extensive understanding of COSHH coupled with frequent adherence to Good Manufacturing Practice and Standard Operating Protocols. • Effectively organised own workload in line with the lab manager. Show less
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University of Leicester
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United Kingdom
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Higher Education
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700 & Above Employee
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Student Ambassador
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Sep 2017 - Oct 2017
Duties included: • Coordinated with other ambassadors to organise campus tours and deal with new queries. • Signposted new students to university faculties, facilities and amenities. Duties included: • Coordinated with other ambassadors to organise campus tours and deal with new queries. • Signposted new students to university faculties, facilities and amenities.
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Primark
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Ireland
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Retail
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700 & Above Employee
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Sales Assistant
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Jul 2016 - Sep 2016
Duties included: • Served customers whilst also handling and dealing with requests and queries. • Financial management as cashier. • Customer complaint handling. • Merchandising. Duties included: • Served customers whilst also handling and dealing with requests and queries. • Financial management as cashier. • Customer complaint handling. • Merchandising.
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Education
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University of Leicester
Bachelor's degree, Medical Microbiology -
Heckmondwike Grammar School
Sixth Form, A-levels