specialists in process validation (Int.)

FOP CONSULTANTS is looking for specialists in process validation at the intermediate level motivated to deliver on mandates for its clients in the pharmaceutical and biopharmaceutical sector. The mandate is to define and lead process validation across the entire lifecycle, to identify critical parameters, execute PPQ campaigns and analyze batch data and to implement continued verification in compliance with GMP, ICH Q8-Q10 and FDA requirements.

• Define the process validation strategy across the lifecycle (design, qualification, continued verification).
• Identify critical quality attributes and critical process parameters.
• Draft and execute process performance qualification (PPQ) protocols.
• Perform statistical analysis of batch data and process capability.
• Investigate deviations and track process-related CAPA.
• Implement continued process verification (CPV) and trend reviews.
• Ensure compliance with FDA guidance, ICH Q8-Q10 and Health Canada GMP.

• Bachelor's or Master's degree in science (chemistry, biochemistry, biology, etc.), engineering (chemical engineering) or any other related discipline.
• Five (05) to ten (10) years of industry experience.
• Three (03) to seven (07) years of experience as a Specialist in Process Validation.
• Sector standards: GMP (Health Canada), FDA 21 CFR 210-211, ICH Q7 to Q10, GAMP 5, ISO 9001.
• Tools and systems: MS Office suite, Veeva Vault, TrackWise, Kneat, MS Project.
• Hold one of the following certifications: ASQ CQE, ISPE GAMP 5, Six Sigma Green Belt.
• The following are considered assets: PMP, ASQ CQA, Six Sigma Black Belt.
• Experience in Canadian public or private organizations.
• Language: French and English

• Remote, Hybrid, On-site

At FOP CONSULTANTS, we invest in the success and well-being of our experts. By joining our team, you benefit from an environment designed to support your performance and respect your work-life balance, including:

• Competitive compensation that reflects your expertise;
• Complete protection through our group insurance plans;
• Professional liability insurance so you can practise with confidence;
• Remote-work flexibility, based on client needs;
• 3 weeks of vacation to recharge;
• 3 paid sick days, to take care of yourself;
• A monthly allowance for your transportation costs;
• Real opportunities for advancement within the organization;
• Ongoing access to training to grow your skills.