Computerized systems validation jobs in Canada | Referso Jobs

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.
Nice to have: pharmaceutical manufacturing operations
Nice to have: liquid processing systems
Nice to have: Health Canada regulations
Nice to have: TrackWise Change Management

Skills

validation experience within a GMP-regulated pharmaceutical, biotechnology, medical device, or healthcare manufacturing environment equipment qualification process validation cleaning validation computerized systems validation data integrity GMP regulations PICs ISO standards regulatory compliance statistical techniques Minitab Statistical Process Control (SPC)

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