Are you looking to build a career as a professional in the pharmaceutical industry? Are you seeking a position in a fast-growing Quebec-based company? We have an opportunity for you!
Who are we?
Founded in 1976, Ropack Pharma Solutions is a Quebec-based family business operating in the pharmaceutical, nutraceutical, and food sectors. Ropack provides comprehensive solutions for the manufacturing, packaging, and clinical trial services of solid oral dosage products. The company is recognized for its reliability and flexibility and is committed to delivering high-quality products while fostering innovation.
Ropack Pharma Solutions is dedicated to offering powders, tablets, and capsules in various formats that exceed client expectations. Our employees are at the heart of the organization, guided by four core values:
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Teamwork
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Passion for success
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Exceeding customer expectations
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People first
Why work at Ropack?
We value the well-being, development, and contributions of our employees. By joining our team, you will benefit from:
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Numerous advancement opportunities in a growing company
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A collaborative and dynamic work environment
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Training and professional development opportunities
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Competitive salary scale
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A generous benefits package
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Paid time off
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Team activities and a positive company culture
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OPUS card discounts
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Free on-site parking
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Stable work schedule
Your role and responsibilities
1. Supervision and Coordination
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Lead the Regulatory Compliance (RC) specialists and assign tasks (internal audits, supplier audits, CAPA, HACCP, etc.);
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Ensure the quality and follow-up of team deliverables (reports, action plans, indicators);
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Provide technical and methodological support to the specialists.
2. Systems and Process Management
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Coordinate activities related to internal audits, CAPA, and HACCP programs with RC specialists;
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Manage the supplier approval and certification program;
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Plan and conduct supplier evaluations (including on-site audits);
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Establish and approve quality agreements with suppliers;
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Maintain updated records of approved/accredited suppliers;
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Ensure compliance of API sites and obtain GMP evidence for import activities;
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Ensure risk analyses, documentation, and quality plans are current and compliant;
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Support the Senior Director in approving and updating QMS procedures.
3. Audits and Inspections
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Represent Ropack during certain client, supplier, certification, or regulatory audits, independently or jointly with the Senior Director or another subject matter expert;
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Participate in preparing regulatory inspections (Health Canada, FDA, NSF, UL, etc.);
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Monitor implementation of corrective action plans and report progress to management.
4. Training and Development
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Oversee planning and delivery of annual GMP/HACCP training; provide annual or initial GMP training as part of the RC training team;
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Develop the skills of the regulatory compliance team through mentoring and support.
5. Reporting and Regulatory Monitoring
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Produce and consolidate performance indicators (KPIs) for regulatory compliance;
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Maintain active regulatory intelligence and communicate relevant changes to the Senior Director and affected teams;
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Contribute to the Annual Quality Review by coordinating data collection and analysis.
6. Executive Support
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Act as a backup for the Senior Director during absences, including delegated authority for approving quality agreements with clients;
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Represent the department on internal committees when assigned;
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Participate in continuous improvement of quality processes and achievement of strategic objectives.
Requirements
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Bachelor’s degree in sciences (accepted by Health Canada for the vault);
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10+ years of experience in the pharmaceutical industry in quality assurance, including team supervision;
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Excellent written and oral communication skills in French and English.
Skills
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Strong knowledge of GMP (FDA, Health Canada, EU), HACCP standards, ISO, and GFSI;
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Attention to detail, quality-focused, observant, analytical, problem-solving skills, autonomous, with recognized communication and team management abilities.
Assets
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Experience managing complex regulatory projects;
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Direct participation in successful FDA/Health Canada inspections.
Job Type: Full-time, Permanent
Location: Hybrid remote work in Anjou, QC H1J 1T7