“FDA” jobs in Canada – Page 32

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• 1mo

  Senior Analyst, QC Compliance (Chemistry)

  Mississauga, ON

  $70k–$108k/yrFull Time

  RB

  Resilience Biotechnologies Inc.

  4+ YOECandidates need demonstrated experience leading OOS and deviation investigations with CAPA closure, authoring SOPs and test methods, and strong chemistry analytical and data analysis skills. Knowledge of cGMPs and USP/EP standards is required, along with the ability to work independently and read, write and follow instructions in English.

  Regulatory compliance, Quality control systems, Manage quality, Inspection, Documentation, Quality assurance

• 1mo

  Directeur(trice) de site I/Site Director

  Saint-Hubert, QC

  Full Time

  LA

  Les Aliments Mejicano Inc.

  7+ YOE2+ MgmtBaccalauréat en administration, ingénierie, sciences alimentaires ou gestion des opérations; Sept ans d'expérience manufacturière, dont deux en direction d'usine; Connaissance de HACCP, BPF/GMP et FDA

  SAP, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Microsoft OneNote

• 1mo

  JDE Developer

  Mississauga, ON

  Full Time

  HE

  HSS Enterprises Ltd.

  5+ YOECandidates need 5+ years as a JDE Developer with hands-on experience in Oracle JDE development tools up to version 9.2, plus a bachelor's degree in a technical field. Strong communication and analytical skills are also required.

  RDA, FDA, TDA, NER, UDO, Orchestration Studio

• 1mo

  Clinical Operations Manager (COM) - Montreal, Canada - Hybrid

  Montréal, QC

  RemoteFull Time

  FF

  FTCAN Fortrea Canada Inc.

  4+ YOECandidates need 4-6 years of clinical research experience, a life science or health degree (or equivalent experience), and knowledge of ICH, GCP and FDA rules. Fluency in French and English, strong organization and the ability to lead junior staff are also needed.

  clinical systems, regulatory systems, finance systems

• 1mo

  Site Activation Partner/Study Start Up Specialist - FSP

  Alberta +3

  Remote

  PI

  Parexel International (Canada) LTD

  2+ YOEParexel International asks for at least 2 years of clinical trial site activation experience, knowledge of ICH/GCP, FDA and local regulations, and fluency in English and a local language. A life sciences bachelor's degree is preferred.

  Clinical trials, Regulatory compliance, Pharmaceutical industry, Google Cloud

  1mo

  Senior Clinical Research Associate - FSP

  Quebec +2

  Remote

  PI

  Parexel International (Canada) LTD

  3+ YOECandidates need at least 3 years of clinical research site monitoring experience, extensive knowledge of ICH/GCP, FDA and local regulations, and a life sciences bachelor's or professional degree. They must be fluent in English and the local language, able to travel 60-80%, and hold a valid driver's licence and passport.

  Trial Master File (TMF)

• 1mo

  Responsable Qualité ESO / ESO Quality Americas Leader

  Baie-D'Urfé, QC

  Full Time

  GP

  Galderma Prod Canada Inc.

  8+ YOEBaccalauréat en sciences ou génie pertinent; 8+ ans d'expérience en qualité dans l'industrie pharmaceutique, cosmétique ou médicale; 5+ ans en production semi-solide à l'échelle mondiale

  Manage quality, Quality assurance procedures, Regulatory compliance, Inspection, Good manufacturing practices, Technical support

• 1mo

  Quality Management System Specialist

  Strathroy, ON

  Full Time

  CC

  Catalent Company

  2+ YOECandidates need a diploma or bachelor's degree in life science or a related field and at least 2 years in quality or operations. Experience in a regulated manufacturing environment is required, with pharmaceutical quality management experience and FDA or Health Canada inspection exposure preferred.

  Microsoft Office Suite, Outlook, Excel, PowerPoint, Word

  1mo

  Director of Quality

  Strathroy, ON

  Full Time

  CC

  Catalent Company

  7+ YOECandidates need a science or technical bachelor's degree and 7+ years of leadership experience in a GMP manufacturing or pharmaceutical setting. They must have hands-on experience hosting and managing FDA and HPFB inspections, and strong communication and Microsoft Office skills.

  Microsoft Outlook, Microsoft Excel, Microsoft Access, Microsoft Word

• 1mo

  PRODUCTION SHIFT MANAGER (Afternoon/Evening Shift)

  Aurora, ON

  Full Time

  PH

  Piramal Healthcare (Canada) Limited

  Candidates need experience leading pharmaceutical or regulated manufacturing, knowledge of cGMP, GDP and safety standards, and skills in team leadership, root cause analysis and lean or Six Sigma methods.

  Good manufacturing practices, Documentation, Housekeeping, Cleaning, Root cause analysis, Scheduling

• 1mo

  Senior Director Systems Development and Integration - Handheld Systems

  Canada

  On-siteFull Time

  WE

  w EPOCAL INC.

  15+ YOECandidates need a systems engineering degree, at least 15 years of medical device or diagnostics product development, and proven leadership of large, global teams. They also need working knowledge of FDA, ISO 13485 and IVDR rules.

  Process improvement, Regulatory compliance, Firmware, Data management, Risk management, Leadership

  1mo

  Director of Assay Development and Consumables Integration - Handheld Systems

  Canada

  On-siteFull Time

  WE

  w EPOCAL INC.

  12+ YOECandidates need at least 12 years of medical device or diagnostics experience, a bachelor's degree in a science or engineering field, and proven leadership of R&D teams. Hands-on skills in electrochemical sensors, reagent chemistry, microfluidics and high-volume plastic manufacturing are required.

  Injection molding equipment, Automation equipment

• 1mo

  Sr. Project Manager, Quality Assurance (QA)

  Burnaby, BC

  $102k–$135k/yrFull Time

  EC

  Evonik Canada Inc._11

  10+ YOE2+ MgmtCandidates need a bachelor's degree in a science or engineering field and ten to twelve years of pharmaceutical or biopharmaceutical QA/QC experience, including at least two years in leadership. Strong cGMP knowledge, experience hosting regulatory inspections and advanced problem-solving and communication skills are required.

  Word, Excel, Access

• 1mo

  Senior Trade Compliance Specialist

  Surrey, BC +2

  HybridFull Time

  

  Finning

  10+ YOEFinning Canada needs 10+ years of customs, trade compliance, export control or duty recovery experience and a diploma or degree in trade, logistics or business. Candidates need deep knowledge of Canadian and U.S. customs rules, USMCA and HS codes, and strong Excel and Power BI skills.

  Excel, Power BI, CARM, Single Window, AES

• 1mo

  Biostatisticien principal du FSP, phases 2 et 3

  Kirkland, QC

  Full Time

  I

  IQVIA: IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences…

  5+ YOEDoctorat ou maîtrise en statistiques ou biostatistiques avec expérience industrielle; Au moins 2 ans d'expérience en essais cliniques de phases 2/3; Maîtrise de R ou SAS

  SAS, R

• 1mo

  Quality Manager

  Lachine, QC

  On-siteFull Time

  SP

  Silgan Plastics Canada

  5+ YOECandidates need five years of quality coordinator, quality engineer or similar experience, and a high school diploma with ASQ certifications. Strong knowledge of quality systems, statistical sampling, SPC and cGMP is essential, along with leadership and clear communication skills.

  Statistical software, SPC software, Computers

• 1mo

  Spécialiste des systèmes de qualité/Quality Systems Specialist

  Vaudreuil-Dorion, QC

  On-siteFull Time

  CH

  CAN Haemotec

  1+ YOEAu moins 1 an d'expérience combinée en ingénierie de la qualité et validation des procédés; Baccalauréat en génie, sciences, chimie ou biologie (préférable) ou diplôme en techniques de laboratoire; Connaissances en IQ/OQ

  SAP, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, instrumentation analytique

• 1mo

  Supervisor, Facility Services

  Whitby, ON

  On-siteFull Time

  

  Patheon Inc

  5+ YOECandidates need a bachelor's degree plus 5 years of experience, or an advanced degree plus 3 years, ideally in pharmaceutical or GMP manufacturing. They must have led maintenance teams, know building management and maintenance systems, and understand regulatory compliance.

  BMS, CMMS, Microsoft Office

  1mo

  Supervisor, Packaging Mechanic

  Mississauga, ON

  On-siteFull Time

  

  Patheon Inc

  5+ YOE2+ MgmtCandidates need a college or technical diploma, at least 5 years of maintenance or set-up experience in a cGMP environment, and 2 years of team lead or supervisory experience. Strong mechanical, electrical and pneumatic knowledge, FDA and GMP understanding, and computer skills are required.

  Microsoft Office, Maintenance work-order system, Packaging equipment, Control systems

  1mo

  QA Manager Documentation Review - Onsite Mississauga

  Mississauga, ON

  On-siteFull Time

  

  Patheon Inc

  8+ YOE3+ MgmtCandidates need a chemistry, biology or biochemistry degree and at least 8 years of GMP experience with a bachelor's, or 6 with an advanced degree. They also need 3 years of people management and deep knowledge of GMP, data integrity and quality systems.

  TrackWise, LIMS, Empower, SAP, MES

• 1mo

  Senior Facilities Engineer (Electrical) - Point of Care - (Ottawa)

  Ottawa, ON

  $87k–$128k/yrFull Time

  AP

  Abbott Point of Care Canada Ltd

  7+ YOECandidates need seven or more years of facilities engineering experience, including leading infrastructure programs and capital projects. Strong knowledge of electrical distribution, HVAC, cleanrooms and validation in a regulated GMP or ISO manufacturing environment is required, and an engineering bachelor's degree, preferably in electrical engineering, is preferred.

  BAS, BMS, UPS, switchgear, transformers, generators

  1mo

  Clinical Data Manager - Point of Care (Ottawa)

  Ottawa, ON

  $87k–$128k/yrFull Time

  AP

  Abbott Point of Care Canada Ltd

  6+ YOECandidates need a university degree, 6 to 10 years of clinical data management experience with EDC and CTMS systems, and knowledge of GCP and 21 CFR Part 11. Programming in SAS, R or Python and strong written and oral communication are also required.

  Zelta EDC, SharePoint, SAS, SAS JMP, R, Python

• 1mo

  Senior Process Engineer (12 Month Contract)

  Vancouver, BC

  

  Aspect Biosystems: Aspect Biosystems is a biotechnology company pioneering the development of a novel category of cellular medicines designed to replace or restore…

  6+ YOECandidates need an M.S. or Ph.D. in chemical, bio or biomedical engineering or a related life science, plus 6 to 8+ years in cell therapy, bioprocess or biologics manufacturing. Strong GMP, DOE and hands-on process characterization experience is required.

  fluidic systems, bioreactors, single-use systems

• 1mo

  Senior Manufacturing Engineer

  Surrey, BC

  $45.67–$56.25/hrFull Time

  

  Industrial Electric Manufacturing: (IEM) is the largest independent full-line manufacturer of electrical distribution equipment and integrated power systems in the U.S.

  7+ YOEIndustrial Electric Manufacturing needs 7 to 10+ years of manufacturing engineering experience, ideally in electromechanical production. Candidates need a degree in mechanical, industrial or manufacturing engineering, plus Lean, Six Sigma, CAD, ERP, MES and automation skills.

  CAD software, ERP systems, Manufacturing execution systems (MES), PLCs, Robotics, Machine vision

18 companies