Job Opportunities

The Computerized System validation Specialist has primary responsibility for the completion of all phases of assigned automation and computer system validation activities ensuring full compliance to regulatory standards and our client requirements.

Responsibilities

Actively completing, coordinating and managing all phases of assigned automation and computer system validation projects and related activities including but not limited to:

• 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;
• Provides coaching and mentoring to the organization staff regarding CSV, SDLC, data integrity, security standards, regulations, guidance and best practices;
• Develops and maintain risk management documentation including software risk assessments;
• Evaluates and define computer system validation approach for applicate software or GxP computerized systems;
• Authors validation project plans, protocols, reports and compiles final validation report summaries as required to meet qualification and validation objectives;
• Evaluates and analyzes qualification/validation data collected while verifying acceptability of the data and compliance with the protocol;
• Conducts validation discrepancy investigations; identifies and implements effective root cause analyses and corrective actions;
• Interacts regularly with project team members and influences overall scope development and communicates with all levels of employees within and outside the team;
• Reviews qualification/validation packages for completeness and accuracy, compliance with policies, procedures and accurate data analysis related to computer system;
• Performs a periodic review of qualified and validated software and computer systems as per corporate procedures;

Requirements

• At minimum, must have a University degree (BSc) in Chemistry, Biochemistry or Microbiology or Bachelor’s degree in Engineering;
• 6+ years’ experience in computer system validation in GxP Regulated environment
• Direct experience with manufacturing operations and biotechnology processes is required.
• Strong organizational skills, excellent writing and communications skills
• Experience with basic applied statistical models a plus
• Knowledge of Industry guidelines (ISPE especially GAMP 5, PDA), US and international regulations (FDA, ICH, ISO, EU, Health Canada) for GMP regulated environments
• Excellent verbal and written communication skills
• Project Management experience
• French Fluency is a must

Additional Information

We are an equal-opportunity employer.

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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

• • 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

• • 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.

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