Gursharan K. Email and Phone Number
Dedicated and results-driven professional with over 5 years of comprehensive experience in Project Management, Clinical Trial Management, Regulatory Affairs, and Quality Assurance. Proven expertise in ensuring the success of clinical and industrial organizations by managing key aspects of project lifecycles, regulatory submissions, and quality control processes. Adept at collaborating with cross-functional teams, implementing operational efficiencies, and maintaining compliance with industry standards. Extensive knowledge of ICH-GCP guidelines, Canadian regulatory frameworks, and quality assurance protocols.
Cliantha Research Limited
View- Website:
- cliantha.in
- Employees:
- 767
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Project AssociateCliantha Research Limited Feb 2023 - PresentMississauga, Ontario, CanadaIn my recent role as a Project Associate at Cliantha Research Ltd, I played a pivotal role in supporting lead project managers in the tracking and management of Clinical Trial Applications and Investigational New Drug Applications. My responsibilities extended to overseeing electronic Trial Master Files, drafting project plans, and coordinating with various stakeholders. Additionally, I managed external vendor activities and served as a subject matter expert, contributing to compliance with regulatory guidelines. -
Regulatory Affairs AssociateCliantha Research Limited Sep 2022 - Jan 2023Mississauga, Ontario, CanadaDuring my Regulatory Affairs Associate Internship at Cliantha Research Ltd, I gained valuable experience drafting, reviewing, and analyzing regulatory submissions for Phase I-III clinical trials. This included submissions to Health Canada in both CTD and eCTD formats, as well as interactions with regulatory health authorities. My role also involved providing regulatory-related advice, maintaining knowledge of the Canadian regulatory landscape, and ensuring timely prioritization of workload to meet deadlines -
Quality Assurance SpecialistWalmart Dec 2017 - Feb 2023Mississauga, Ontario, CanadaExperienced professional with a comprehensive background in inventory management and quality assurance. Proficient in executing inventory cycle counts, audits, and adjustments to ensure accuracy. Skilled in administering Warehouse Management System item/slot management, TPR report preparation, and maintaining financial integrity for Walmart. Possesses a detailed understanding of perishable distribution networks, supply chain processes, and store/PDC operations. Adheres to company policies, guidelines, and quality requirements, demonstrating expertise in fresh quality within the food distribution industry. Trained in Occupational Health and Safety, WHMIS, SOPs, GMPs, and Good Laboratory Practices. Conducts quality audits, verifies reports for inventory accuracy, and follows Quality Assurance policies. Operates power equipment safely and acts as a resource for staff, referring complex issues to QA management. Familiar with Canadian Food Regulations, HACCP, and actively supports third-party CFIA audits. -
SupervisorSecond Cup Jan 2016 - Nov 2017Toronto, Ontario, CanadaProven leadership in supervising the preparation of European drinks, managing orders, and delivering exceptional customer service. Proficient in planning and scheduling staff to ensure optimal coverage for shift needs. Dedicated to efficient product preparation, emphasizing the highest quality and minimizing overproduction to reduce waste. Adheres to local and national health and food safety codes, as well as company safety and security policies.Demonstrates effective monitoring of product levels, ensuring replenishment as needed, and delegates responsibilities to ensure completion of cleaning and secondary duties. Ensures strict adherence to health and safety regulations, cultivating a cooperative work climate for enhanced productivity and morale.Acknowledged for resolving customer complaints, rectifying issues promptly, and ensuring the highest level of satisfaction. Actively volunteered in Dine Safe inspections, showcasing a commitment to maintaining and exceeding industry standards. -
Sales And Marketing AssociateSecond Cup Coffee Company Inc. Dec 2014 - Dec 2015Toronto, Ontario, CanadaHighly skilled in delivering quality beverages with a focus on latte art. Proficient in maintaining cleanliness and organization within the store, contributing to a positive customer experience. Demonstrates efficiency in cash handling and adeptly resolves customer complaints with a pleasant demeanor.Committed to following store guidelines, actively contributing to increased store productivity. Ensures store safety and security through strict adherence to operating procedures. Thrives in a fast-paced environment, showcasing adaptability by working flexible hours -
Quality Assurance TechnicianJackson Laboratories Pvt. Ltd. Apr 2013 - Apr 2014Punjab, IndiaInstrumental in formulating Good Manufacturing Practices (GMPs) and implementing HACCP and Root Cause Analysis to enhance product safety and reduce errors. Led training, development, coaching, and performance appraisal processes for team members, ensuring a skilled and motivated workforce.Managed the timely and accurate completion of environmental sampling and microbiological testing for all products, providing crucial technical support to the QA team. Actively participated in maintenance and sanitation services, conducted data entries, and maintained QA/QC reports with precision.Contributed to workplace safety through daily inspections, addressing concerns promptly. Reviewed and audited laboratory reports daily, ensuring accuracy and compliance. Successfully managed scheduling and staffing to meet workload demands and played a key role in updating laboratory Standard Operating Procedures (SOPs) as needed.
Gursharan K. Education Details
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Clinical Research, Pharmacovigilance And Regulatory Affairs -
Biotechnology -
Pharmacy
Frequently Asked Questions about Gursharan K.
What company does Gursharan K. work for?
Gursharan K. works for Cliantha Research Limited
What is Gursharan K.'s role at the current company?
Gursharan K.'s current role is Project Management | eTMF/TMF | Regulatory Affairs | Quality Assurance.
What schools did Gursharan K. attend?
Gursharan K. attended Academy Of Applied Pharmaceutical Sciences, Centennial College, Punjab Technical University.
Who are Gursharan K.'s colleagues?
Gursharan K.'s colleagues are Devendra Koshti, Shweta Chunara, Mohammed Sohail, Rutvi Patel, Ujas Patel, Farjana Jahan, Amit Shah.
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Gursharan Babbrah K.Dutch
Interior Designer At Kuwait Dutch Company For Renovation ContractingKuwait1hotmail.com
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