Digital Compliance Specialist

Contract, Temporary Full-Time
Montreal, Quebec
Posted 1 year ago

Digital Compliance Specialist will be a key player in our client’s Digital Compliance Projects in the regulated industries:

This position involves leading Digital compliance and validation activities often working cross-functionally with various department to ensure quality is met using a risk-based approach. If you are an experienced, result-driven leader, with extensive validation experience, this is the role for you! This is a full-time, permanent position in a growing consulting company with a great culture and environment that supports personal and professional growth.

Responsibities

  • Development of project plans to support computerized system validation planning
  • Development, review and/or approval of specification and verification documents as per CSV lifecycle documentation and deliverables
  • Development, support and facilitation of change management process for computer and automation systems
  • Analyze and perform assessments using a GAMP risk-based approach for changes on validated computerized systems impacting data integrity, hardware interactions and security, and assign appropriate levels of validation accordingly
  • Evaluate testing procedures for continuous monitoring
  • Investigate direct compliance issues
  • Assess product, compliance, or operational risks and develop  risk management strategies
  • Identify compliance issues that require remediation
  • Communicate written policies and procedures across the organization
  • Collaborate with senior management and the appropriate department heads
  • Advise senior management and business partners about implementing compliance programs
  • Review continuous monitoring and continuous documentation of systems
  • Report compliance violations

Requirements

  • B.Sc. in Engineering, Microbiology, Chemistry, Biotechnology or Biochemistry, or related scientific background
  • 5-10+ years’ experience in Life Sciences/Regulated Industry compliance
  • Project management certification (an asset)
  • Lean Six Sigma certification (an asset)
  • Strong Compliance experience (quality, CSV, DI, Annex 11, 21 CFR Part 11) in GxP regulated environment
  • Excellent written and verbal communications (English and French), and strong interpersonal skills.
  • Autonomous and able to work independently
  • Confidence and ability to professionally present information to internal and external stakeholders.
  • Project coordination/management expertise
  • Attention to detail in the planning and monitoring of actions to carry out the tests and resolve the problems encountered
  • Excellent problem solving and root cause researching skills

Additional Information

We are an equal opportunity employer.

Job Features

Job CategoryDigital Quality Management, Digital Validation

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