Specialist, Compliance-GQC-QSMR R

Job Summary

Responsible for developing and analysing quality metrics data and generating quality reports. This role independently provides technical leadership and expertise with respect to the Deviations and CAPA Process. This position also supports compliance activities such as escalation, quality risk review board, site management review and audits for the Richmond Hill site.

Job Responsibilities

• Analyze QPI/OQI metrics for the site, including but not limited to Deviation/CAPA/Change Controls/Product Review/LIRs/Complaints and other metrics report for management. Perform trending/reporting to monitor the overall health of the Pharmaceutical Quality System. Lead change to respond to issues and concerns identified, consistent with quality programs and regulatory requirements.
• Perform trending and reporting to monitor effectiveness of investigations and CAPAs. Analyze cause and defect items and liaison with responsible departments to resolve issues and reduce overall risk.
• Manage the Deviation and CAPA system, including facilitation of Deviation Review meetings. Review on-going progress on all open Deviations/CAPAs. Notify appropriate individuals and area management on status and escalate issues related to overdue tasks for areas.
• Support management in preparation of Escalation/Site Management/Quality Risk Review Board meetings. Preparation meeting agendas and minutes ensuring decisions are appropriately documented and action items are addressed/followed-up. Act as designate and facilitate meeting including decision making in the absence of Manager.
• Maintain and track status of risk registry for the site. Liaison with responsible departments to perform risk assessment and develop risk control strategy.
• Provide necessary support before, during and after Regulatory and Customer inspections including logistics, participation in inspection team, provision of requested document, trend reports, coordination of audit responses etc.
• Recommend/participate in the implementation of process improvement initiatives to maximize efficiency and improve compliance. Troubleshoot problems and recommend solutions.
• Ensure that all work is performed in full compliance with GMP, GLP, SOD, and safety standards. Work in accordance with all regulatory and compliance requirements.
• Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities.
• Works as a member of a team to achieve all outcomes.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Performs all work in support of our Values: Collaboration, Courage, Perseverance and Passion.
• All other relevant duties as assigned.

Job Requirements

• Education

• Bachelor’s Degree in Science

• Knowledge, Skills and Abilities
  • Demonstrate leadership skills with decision making ability, excellent problem solving skills, analytical and critical thinking
  • Superior organizational, interpersonal and communication skills
  • Ability to manage time effectively, work independently and manage multiple priorities in a fast-paced changing environment
  • Good command of the English language, both written and verbal
  • Strong understanding of Canadian and cGMP regulations
  • High proficiency with Microsoft Office, QMS Trackwise and SAP
• Experience
  • Minimum 5 years experience in pharmaceutical industry, preferably in a Quality Assurance
  • Experience in Pharmaceutical Manufacturing operations and controls, change management processes, regulatory affairs, validation and leadership
  • Experience in project management and quality risk management