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Compliance Project Leader

Date: Jan 4, 2021

Location: Etobicoke, ON, CA, M9W 6Y3

Company: Apotex

 

About Apotex Inc.

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations.  Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.

 

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 site.

**Please note, this is a 12-months contract, eligible for benefits**

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 in a safe manner collaborating as a team member to achieve all outcomes.
  • Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
  • Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
  • All other relevant duties as assigned

Job Requirements

 

  • Bachelors degree in science
  • Experience with Quality Assurance in the pharmaceutical industry
  • 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 Experience

 

 

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.