Lead/Support the continuous operation of AbbVie Bioresearch Center’s IT and Automation systems, and in establishing a stable and future-ready digital foundation in accordance with the company’s Advanced North Star capabilities.
Responsibilities
Act as the lead technical expert for Automation Applications, Process Control and Manufacturing Execution Systems
Maintain system availability and prepare performance metrics
Provide input and recommendations regarding business continuance issues and operating system improvements
Monitor, insure compliance, and conform to all regulatory and company mandates
Provide guidance, technical advice, planning and project management
Requirements
Bachelor’s Degree in Computer Science, Engineering, or related discipline
Supports equipment qualification, analytical instrument qualification, and computerized systems validation, ensuring compliance with GxPs, 21 CFR Part 11, Annex 11, and USP standards, while leading Data Integrity initiatives across the site.
Responsibilities
Support commissioning, qualification, and computer system validation projects
Write, execute, review, and approve validation protocols, reports, and lifecycle documents
Collaborate with IT, QC, Automation, QA, and vendors for qualification and validation activities
Perform change assessments and risk assessments
Act as SME for validation strategy for equipment, systems, computers, and methods
Lead validation initiatives for manufacturing equipment, processes, cleaning and computerized systems to ensure compliance with regulatory and quality standards.
Compensation
The estimated salary range for this position is $72,080.00 - $108,120.00 CAD annually, which reflects base salary as well as estimated target payout under the Management Incentive Compensation Plan.
Responsibilities
Lead the development, execution, and completion of validation programs for manufacturing equipment, processes, cleaning and computerized systems to ensure a validated state of control.
Author validation protocols and reports, analyze validation data, and apply statistical techniques to demonstrate compliance with regulatory and quality requirements.
Partner with Engineering, Production, Quality Control, and external vendors to plan, coordinate, and execute qualification activities including IQ, OQ, and PQ protocols.
Serve as a validation subject matter expert by providing technical guidance on process validation, cleaning validation, equipment qualification, computerized systems validation, and data integrity practices.
Support change control and quality system activities by assessing validation impacts, contributing to investigations, and leading resolution of validation-related non-conformances and corrective actions.
Requirements
Bachelor's degree in engineering, Chemistry, Microbiology, Pharmacy, Life Sciences, or a related scientific discipline.
We are looking for a highly motivated and energetic professional to join our team as a QA Compliance Analyst in Brantford, ON.
Compensation
The annual salary range is $50,000–$65,000, depending on qualifications and experience.
Responsibilities
Develop, implement, and maintain departmental procedures, analytical test methods, and quality systems in compliance with GMP and applicable regulatory requirements.
Oversee daily Quality Assurance and Quality Control operations, including staff supervision, training, work assignments, performance management, and departmental budgeting.
Manage quality compliance programs, including Change Control, Deviations, CAPA, internal audits, and supplier audits.
Oversee final product release, product recalls, returns, customer complaints, and approval of analytical methods, SOPs, and controlled documents.
Ensure regulatory compliance, coordinate regulatory audits, prepare audit responses, and maintain effective calibration and preventive maintenance programs.
Requirements
Bachelor’s degree in Chemistry
Bachelor’s degree in Microbiology
Bachelor’s degree in a related scientific discipline
Strategic Quality leader for digital transformation initiatives, ensuring emerging technologies, platforms, automation, and AI strengthen product quality, patient safety, data integrity, and regulatory compliance.
Responsibilities
Develop and execute a multi-year Digital Quality roadmap aligned with Sharp's business strategy.
Establish Quality governance frameworks that ensure appropriate oversight, ownership, accountability, and lifecycle management of digital quality systems.
Support the integration of digital platforms and data architectures to enable connected, efficient, and compliant end-to-end business processes.
Serve as the Quality representative and advisor for enterprise digital transformation initiatives.
Champion the adoption of modern quality practices that leverage digital technologies, automation, advanced analytics, and AI.
Quality Engineer I, QA SystemsBaxter International Inc. · Alliston, Canada