обновлено 7 часов назад
Quality Assurance Specialist
76 200 - 110 100$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Assurance Specialist (Biopharmaceutical Manufacturing): Providing quality oversight for shop-floor manufacturing activities and licensed products with an accent on cGMP compliance, deviation investigations, and science-based batch decisions. Focus on leading root-cause analysis and CAPA activities, reviewing GxP documentation, supporting audits and inspections, and driving quality improvements.
Location: Toronto, ON; onsite
Salary: 76,200.00–110,100.00 annually
Company
is a global biopharmaceutical company developing medicines and vaccines, with a focus on human health and scientific innovation.
What you will do
- Provide quality oversight and guidance for shop-floor and operational activities within the Formulations, Filling and Packaging area.
- Coach production staff and promote compliant execution, strong process knowledge, and risk-based decision-making.
- Lead and support deviation investigations, including problem definition, root-cause analysis, CAPAs, and compliance-based batch decisions.
- Review and approve deviations, SOPs, CAPAs, change controls, batch records, logbooks, protocols, reports, and other GxP documentation.
- Represent Quality Assurance on change control, deviation review, and quality improvement committees.
- Participate in self-inspections, internal reviews, external audits, regulatory inspections, gap remediation, and site projects.
Requirements
- Bachelor of Science degree and 3 or more years of relevant experience in a pharmaceutical or biological manufacturing environment.
- Strong leadership, management, influencing, and communication skills.
- Extensive knowledge of cGMPs, compliance trends, inspections, and audits.
- Strong problem-solving, root-cause analysis, and investigation skills.
- Experience with continuous improvement methodologies and risk-based approaches.
- Ability to work onsite in Toronto, ON.
Culture & Benefits
- Supportive, future-focused environment centered on scientific innovation and improving patient health.
- Opportunities for career growth through promotion or international and lateral moves.
- Employee rewards and benefits programs.
- Healthcare, prevention, and wellness benefits for employees and families.
- Equal opportunity workplace with accommodation available during the recruitment process.
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