ALTEN Canada
Job Summary:
We are seeking a Quality Validation Specialist to join our dynamic Validation Team. This role plays a critical part in ensuring the quality and compliance of validation activities across various functions such as process validation, cleaning validation, C&Q, and sterility assurance. The ideal candidate brings a strong background in GMP regulations and a flexible, collaborative approach to quality oversight in a fast-paced, project-driven environment.
Key Responsibilities:
- Provide quality oversight for validation activities including process validation, cleaning validation, sterility assurance, equipment/utility qualification, and computerized systems validation.
- Review and approve validation protocols and reports in compliance with internal procedures and regulatory standards.
- Participate in the evaluation and approval of change controls, deviations, and CAPAs related to validation and manufacturing activities.
- Collaborate with cross-functional teams to ensure validation activities align with project timelines and regulatory expectations.
- Support sterility assurance programs and participate in continuous improvement initiatives.
- Maintain alignment with GMP/cGMP, Health Canada, and FDA regulations.
- Adapt to shifting focus areas as project priorities evolve (e.g., formulation, filling, labeling, packaging).
- Support regulatory inspections and audits as required.
Qualifications:
Must-Have:
- Bachelor’s degree in Science, Biotechnology, or Chemical Engineering.
- Minimum 5 years of experience in a quality-related role within a GMP environment.
- Proven experience overseeing validation activities (process, cleaning, sterility assurance, equipment/utility, or computerized systems).
- Solid understanding of Quality Management Systems including deviation, change control, and CAPA processes.
- Experience in vaccine operations (formulation, filling, labeling, packaging) or direct oversight of such activities.
- Excellent communication, technical writing, and documentation skills.
- Strong computer literacy and ability to work in a digital quality system environment.
Nice to Have:
- Hands-on operational experience in manufacturing or project-based environments.
- Experience with ERP systems and Electronic Batch Records (EBR).
- Exposure to regulatory inspections (Health Canada, FDA, etc.).
- Sterile manufacturing or aseptic processing experience.
- Experience in developing or delivering training related to quality and validation topics
Why Join Us?
ALTEN Canada fosters a dynamic and collaborative work environment where team members are empowered to unleash their full potential. We believe in investing in our talent, offering stimulating experiences, and supporting professional growth and development at every turn.
As part of our commitment to our team members, we offer a comprehensive benefits package including
• Collective Insurance & RRSP
• Corporate Discounts
• 4 weeks of vacation
• Numerous corporate activities.
• Personalized professional development plans
Join ALTEN Canada and embark on a journey of endless possibilities, where your talents are celebrated, and your ambitions are nurtured. Experience the difference of working with a company that values innovation, collaboration, and excellence in every endeavor.
ALTEN CANADA is committed to promoting diversity, equity, and inclusion. We strive to provide a work environment where every individual feels welcomed, valued, and respected, allowing them to thrive to their full potential. This includes our dedication to offer accessibility measures to those who require them. Should you require any accommodation during our recruitment process, please reach out to us.
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