Quality Assurance Specialist

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Employer - Rapid Dose Therapeutics Corp.
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Burlington, ONRapid Dose Therapeutics Corp. (RDT) is a publicly-traded Canadian life sciences company that provides innovative, proprietary drug delivery technologies designed to improve outcomes and quality of lives. RDT offers Quick, Convenient, Precise and Discreet™ choices to consumers. RDT is focused and committed to clinical research and product development for the healthcare manufacturing industry, including nutraceutical, pharmaceutical and cannabis industries. Rapid Dose Therapeutics is committed to continually create innovative solutions aimed at multiple consumer segments and future market needs — including humans, animals and plants.We are seeking an experienced Quality Assurance Specialist to guide the development, implementation and compliance of all qualification procedures, validation of methods and processes for our raw materials, finished products, and production processes at our Canadian head office located in Burlington, Ontario. This is an excellent opportunity to be a key contributor in an innovative life science company within the fast-growing natural health products industry. For more information about Rapid Dose Therapeutics, visit www.rapid-dose.com .Summary of Job FunctionsResponsible for researching, coordinating and implementing a complete set of quality compliance procedures for testing methods, materials and product qualification and method validation, in accordance with quality and regulatory guidelines issued by Health Canada directorates, cGMP and Cannabis Act.Key Duties and ResponsibilitiesDetermine qualification requirements and provide quality assurance solutions that satisfy Health Canada and US-FDA requirements.Develop policies and procedural framework to support a Quality Management System (QMS), that includes risk assessments and mitigation steps.Prepare Quality Assurance protocols (IQ/OQ/PQ) as guidance reports for validating all raw materials, equipment, operational processes, finished products and quality validation data in all aspects of operations, in compliance with Health Canada’s directorates.Coordinates the preparation and submission all quality assurance, validation and regulatory activities in compliance with cGMP guidelines for Natural Health Products and Pharmaceuticals.Ensures that all activities are in compliance with GMP, Health Canada and US-FDA requirements; Responsible for representing the company’s QA/QC Department in all reports in relations to Health Canada, FDA.Write and review annually all standard operating procedures (SOPs) required to maintain GMP production and Health Canada site licenses.Develop and manage relationships with various vendors, suppliers and test lab facilities.Participation in audits by health authorities.Minimum Skills and ExperienceBachelor’s Degree (Science or Engineering), preferably in the fields of (bio)chemical sciences, chemical (bio)engineering, materials science.5-7 years of experience in a quality position within the pharma, nutraceuticals industry.Strong understanding of GMP, GLP guidelines from Health Canada, US-FDA is expected; experience with qualification of Equipment, Process and Method Validation is required.Experience writing, reviewing, and maintaining Standard Operating ProceduresProficient in use of standard business office software (e.g. Microsoft Office suite of software and apps); knowledgeable of commonly used QMS software systems.Strong written and oral communication skills in order to prepare reports and procedures and commun

Location - Burlington, ON
Date Posted - 07 May 2019
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