The Quality Consultant is responsible for supplying establishment, validation, operational and other quality assurance consulting services to regulated industries, including those in the international Medicinal Product, drug, medical devices, and natural health products spaces.Responsibilities include:Applying your scientific and regulated product knowledge to fulfill client projects, either remotely, or onsiteLifecycle management of pharmaceutical quality systems, including management of customer quality manuals and product documentationQualification and validation of facilities, equipment and computerised systemsConducting supplier quality and GMP evidence auditsAuthoring and executing compliance approaches for site licensing or remediation.Hands-on application and management of quality tasks, at all stages of the drug manufacturing and supply lifecycle, with a focus on:Quality risk managementEquipment and process validationElectronic systems validation and governancePost-market product related activities (e.G., Stability and Annual product review, trending)Reporting and management review functionsCorrective Action managementAnalytical test validation and result reviewQuality document review and approvalRegulatory authority audit hostingAnnual product quality review, trending and stability performance reviewSkills and Job-Related Experience:Sound knowledge of quality assurance terminology,



International and Health Canada Good Manufacturing Practices (GMPs)Demonstrated experience applying quality standards, including good manufacturing practices (GMP), good laboratory practices (GLP), good distribution practices (GDP) and as applicable good clinical practices (GCP)Awareness and experience in developing specified quality system components, such as a quality manual, site master file and validation master planCommunicate technical information effectively to peers, management, customers using language, graphics, and computer skills.Strong organizational and time management skills, combined with a proven ability to meet strict and established timelines.Solid problem-solving skillsStrong written and oral interpersonal and communication skillsOther language skills are an assetCapacity for pharmacovigilance activities an assetKnowledge in interpretation of regulations, labelling reviews, compiling regulatory e CTD submissions (drug identification number – DIN), drug establishment licence (DEL), new drug submission (NDS) is an assetEducational Requirements:Post Secondary Quality Assurance and/or Regulatory required (University Degree and/or College Diploma/Certificate or equivalent experience).Areas of Specialization: Quality Assurance, regulatory affairs, cannabis, scientific/pharmaceutical industries#J-18808-Ljbffr

📌 Gmp Quality Consultant (Pharma) (Toronto)
🏢 RQC
📍 Toronto