Pharmaceutical Compliance Specialist Gmp
Jubilant HollisterStier LLC
GMP compliance and audit readiness define this onsite Specialist role at Jubilant HollisterStier in Kirkland, Quebec, supporting pharmaceutical quality systems.The Specialist, Compliance supports Quality Systems & Compliance at Jubilant HollisterStier. You will monitor regulatory requirements, follow CAPAs, oversee supplier quality activities, and strengthen inspection readiness. The work supports sterile injectable vials, lyophilized products, and allergenic extracts within the Jubilant Pharma family.Key Responsibilities:
Support audit readiness, self-inspections, and regulatory inspection preparationTrack CAPAs, effectiveness checks, findings, and compliance actionsMonitor GMP updates and participate in gap assessmentsSupport supplier audits, quality issues, and Quality AgreementsPrepare compliance dashboards and maintain inspection-ready recordsRequirements:
Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or related disciplineMinimum five years of pharmaceutical industry Quality experienceExperience in a sterile manufacturing facility preferredWorking knowledge of Health Canada, FDA, and EU GMP regulationsBilingual French and English, with English proficiency requiredApply GMP knowledge, CAPA follow-up, and regulatory surveillance skills to advance compliance at Jubilant HollisterStier.
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Support audit readiness, self-inspections, and regulatory inspection preparationTrack CAPAs, effectiveness checks, findings, and compliance actionsMonitor GMP updates and participate in gap assessmentsSupport supplier audits, quality issues, and Quality AgreementsPrepare compliance dashboards and maintain inspection-ready recordsRequirements:
Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or related disciplineMinimum five years of pharmaceutical industry Quality experienceExperience in a sterile manufacturing facility preferredWorking knowledge of Health Canada, FDA, and EU GMP regulationsBilingual French and English, with English proficiency requiredApply GMP knowledge, CAPA follow-up, and regulatory surveillance skills to advance compliance at Jubilant HollisterStier.
#J-18808-Ljbffr
Vacancy posted 1 hour ago
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