Compliance Project Leader

Apotex Inc. - Etobicoke, ON (14 months ago)

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Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.

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 Etobicoke site.

Job Responsibilities
Develop, compile and analyze daily, weekly, monthly and quarterly QPIs Metrics for the Etobicoke site, including but not limited to Deviation/CAPA/Change Controls/Product Review/Lab LIRs/Complaints and other Metrics Report for management.
Perform trending and reporting of Quality Performance Indicators to monitor the overall health of the Pharmaceutical Quality System. Lead change to response to issues and concerns identified, consistent with quality programs and regulatory requirements.
Perform trending and reporting of Deviations 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 the Weekly 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.
Act as Super User and Certified trainer for the Trackwise system. Train all new staff on Trackwise system as required. Work closely with Global team to develop new programs and systems that improve the overall functionality of the Deviation system including validation activities.
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.
Effectively communicate at all levels within the organization (including Apotex affiliates) and with external customers.
Recommend and participate in the implementation of process improvement initiatives to maximize efficiency and improve compliance.
Troubleshoot departmental problems and make recommendations for solutions in consultation with other relevant staff.
Ensure that all work is performed in full compliance with GMP, GLP, SOD, and established safety standards.
Works as a member of a team to achieve all outcomes.
Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance and Passion; Demonstrates strong and visible support of our values.
Performs all work in accordance with all established regulatory and compliance and safety requirements.
All other duties as assigned.

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Job Requirements
Bachelors degree in science
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
Demonstrate leadership skills with decision making ability and excellent problem solving skills including 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 and changing environment
Good command of the English language, both written and verbal
Strong understanding of Canadian and cGMP regulations

High proficiency with Microsoft Office, Trackwise and SAP

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.