POSITION DESCRIPTION

FOP CONSULTANTS is looking for specialists in quality assurance at the intermediate level motivated to deliver on mandates for its clients in the pharmaceutical and biopharmaceutical sector. The mandate is to maintain the pharmaceutical quality system in compliance with GMP and ICH Q10 and to approve GMP documentation, manage deviations, CAPA and changes, conduct audits and support regulatory inspections.

KEY RESPONSIBILITIES

- Maintain and improve the pharmaceutical quality management system (ICH Q10).
- Review and approve batch records, procedures and GMP documentation.
- Manage deviations, CAPA, changes and complaints.
- Conduct internal and supplier audits and follow up on findings.
- Participate in Health Canada and FDA regulatory inspections.
- Produce annual product reviews and quality indicators.
- Train personnel on GMP and data integrity.

CANDIDATE PROFILE

- Bachelor's or master's degree in science (chemistry, biochemistry, biology, pharmaceutical, pharmacovigilance, etc.), 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 Quality Assurance.
- Sector standards: GMP (Health Canada), FDA 21 CFR 210-211, ICH Q7 to Q10,



GAMP 5, ISO 9001.
- Tools and systems: MS Office suite, TrackWise, Veeva Vault, SAP QM, Power BI.
- Hold one of the following certifications: ASQ CQA, ASQ CQE, ISO 9001 Internal Auditor.
- The following are considered assets: ASQ CMQ/OE, Six Sigma Green Belt, ISO Lead Auditor.
- Experience in Canadian public or private organizations.
- Language: French and English

WORK MODE

- Remote, Hybrid, On-site

WHAT WE OFFER

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;
- Skilled 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.

📌 specialists in quality assurance (Int.) (Quebec City)
🏢 FOP Experts Conseils
📍 Quebec City