Regulatory / Gmp Sme Jobs in Ottawa, Ontario, Canada
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Ottawa, Ontario, Canada
Senior Regulatory / GMP SME (QC Laboratory)
About the role
Job Summary Seeking a Senior Regulatory / GMP SME with extensive experience in QC laboratory operations, GMP compliance, data integrity, regulatory inspections, and laboratory remediation programs within pharmaceutical or biotechnology environments.
Key Responsibilities Conduct GMP compliance and gap assessments of QC laboratory systems, processes, procedures, and documentation. Evaluate laboratory operations for compliance with GMP, Data Integrity, and regulatory requirements. Develop remediation strategies, corrective action plans, and risk-based compliance improvements. Review SOPs, CAPAs, deviations, investigations, OOS/OOT processes, and laboratory controls. Support regulatory inspections, audit readiness, and compliance monitoring activities. Verify implementation and effectiveness of corrective actions.
Required Qualifications 10+ years of GMP Quality or QC Laboratory experience. Strong expertise in GMP regulations, QC laboratory operations, Data Integrity, Quality Systems, and regulatory inspections. Proven experience conducting GMP gap assessments and remediation projects. Experience supporting FDA, Health Canada, and other regulatory agency inspections.
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About Intellectt Inc
Welcome to Intellectt, where the convergence of emerging technologies, domain expertise and innovation drives excellence. Intellectt is a leading provider of Engineering, IT, and consulting services. Our dedication to customer success and our ability to scale on demand have propelled us to become one of the fastest-growing companies in the technology services segment in the US, over the last five years. Intellectt offers deep domain expertise in manufacturing, medical devices, healthcare, banking, financial services and other industries, alongside robust capabilities in emerging technologies like Artificial Intelligence (AI), NLP, Block Chain, Cloud and others. This unique combination enables our customers to navigate the complexities of today's technology and business landscape in order to achieve their goals.