Compliance Specialist

Date: Jun 21, 2019

Location: North York, ON, CA, M9L 1T9

Company: Apotex

 

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

 

 

This is a QA role that is responsible for the execution of audits governed by GMP in accordance with site policies, procedures and regulation. The position is also responsible for providing leadership with a clear understanding of compliance status, any gaps identified, potential impact, risk management and that quality systems have been implemented, maintained and remain effective.

This role is also 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 Signet site.

Job Responsibilities
  • Assist the Manager, with inspection readiness tasks and provide logistical support for Regulatory, Customer and Corporate audits. Follow up on commitments made in responses and compile information to be verified during subsequent audits.
  • Coordination of audit responses.
  • Review regulatory trends, global industry trends and affiliate compliance gaps.
  • Maintain & track status of risk registry for the site. Liaison with responsible departments to perform risk assessment and develop risk control strategy.
  • Maintain Site Master File (SMF).
  • Assist with preparation of customers questionnaires for existing and new customers and GMP site registration packages for global markets.
  • Analyze QPI and 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 and 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 and CAPAs. Notify appropriate individuals and area management on status and escalate issues related to overdue tasks for areas.
  • Support management in preparation of Escalation and 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.
Job Requirements

 

  • Bachelrs degree in science

Knowledge, Skills and Abilities

  • Experience in Pharmaceutical Manufacturing perations and controls, change management processes, regulatory affairs, validation and leadership
  • Experience in prject management and quality risk management
  • Demnstrate leadership skills with decision making ability, excellent problem solving skills, analytical and critical thinking
  • Superir organizational, interpersonal and communication skills
  • Ability t manage time effectively, work independently and manage multiple priorities in a fast-paced changing environment
  • God command of the English language, both written and verbal
  • Strng understanding of Canadian and cGMP regulations
  • High prficiency with Microsoft Office, QMS Trackwise and SAP 

Experience

  • Minimum 5 years’ experience in pharmaceutical manufacturing regulatry and customer inspections, change management processes, regulatory affairs, validation and leadership

 

 

 

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.

 

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