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 departments 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
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- 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 the 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
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- 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 research skills
Additional Information
We are an equal opportunity employer.