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Specialist, GMP Compliance & Training

APOTEX

This is a Contract position in Etobicoke, ON posted January 8, 2022.

 

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 planning and execution of quality risk assessments on the shop floor in manufacturing, packaging and warehouse to evaluate adherence to internal standards and GMP regulations, and for delivering annual GMP training program for personnel within Operations at the site in order to maintain a high level of compliance.

Job Responsibilities

GMP Training: 
1.Deliver GMP and Compliance training programs.
2.Monitor and enhance shop floor training programs to ensure compliance with internal standards and health authority regulations.
3.Effectively work with site department’s management to ensure that course content, learning objectives, and supporting materials accurately reflect business processes, and current regulatory standards.
4.Monitor training gaps for assigned client groups and work with management to close gaps. 
5.Ensure that all related training documentation is consistently and systematically maintained in compliance with internal and regulatory standards.  This includes course materials, and training records.
6.Prepare monthly GMP training metrics and present at the site management review meetings, when required.
7.Effectively communicate and liaise with necessary party to establish an efficient training schedule, and determine documentation and logistical needs as required.

 

Continuous Compliance Improvements (CCI):
8.Plan and execute Quality Risk Assessments and GMP walkthrough for continuous compliance improvements on the shop floor under defined protocols to evaluate adherence to internal standards and GMP regulations. 
9.Prepare risk assessments summary reports and meet with department leadership team to review the findings and, as necessary, assist with the timely closure of identified gaps.
10.Use data collected during risk assessments to develop the annual GMP trends training for personnel within Operations at the site with focus on shop floor execution activities. 
11.Assist Compliance team at the site with preparation and execution of internal, regulatory and customer audit on the shop floor.
12.Responsible for suggesting/evaluating changes to the system, making changes to the system, working with departments outside QA to improve quality and compliance as related to the system, producing reports as required, and training personnel on the system.
13.Write, update and review proposed Standard Operating Procedures, as required.
14.Create, maintain, analyse and report metrics enabling constant improvements to the training and audit program. Identify trends and patterns and make recommendations to management. 
15.Helps define and implement processes supporting Audit execution, writing and updating 
16.Interacts primarily with co-workers, supervisor, internal & external stakeholders and management.  Leads interactions with senior management and internal & external customers to negotiate actions. 
17.Ensure that all work is performed in full compliance with Good Manufacturing Practices, Good Laboratory Practices, Standard Operating Procedures, all regulatory requirements, and established safety standards.
18.Work independently or in a team, either within QA or with various departments, to ensure that all work is completed in a timely fashion to meet the business needs.
19.Serve as the Quality representative on cross-functional and cross-site teams for improvement to quality systems, if required.
20.Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, Passion, 
21.Performs all work in accordance with all established regulatory and compliance and safety.

22. All other duties as assigned.

 

Job Requirements

  • Bachelor of Science Degree (or equivalent) in a related discipline.
  • At least 5 years’ experience in the pharmaceutical industry, in a QA or QC role.
  • Strong knowledge and application of cGMPs/GMPs in a pharmaceutical manufacturing and or QA/QC environment.
  • Knowledge and application of Adult Learning Principles, needs for assessment, instructional design, development and delivery of training is an asset.
  • Ability to interpret and relate Quality standards for implementation and review of SOPs and Work Instructions as required.
  • Experience conducting GMP audit is an asset.
  • Ability to manage multiple priorities in a fast-paced and changing environment.
  • Excellent organizational skills and the ability to manage time effectively.
  • Experience with Microsoft Computer Products (Word, Excel, Access, Project). Experience with SAP is an asset.
  • Must be able to work independently with minimal supervision
  • Must be detail-oriented, accurate and reliable
  • Strong ability to communicate clearly and professionally both in writing and verbally, in English
  • Superior interpersonal skills and ability to work effectively in a team environment within and outside the department.

COVID-19 VACCINATION POLICY: In accordance with Apotex Inc. (“Apotex”) policy, as of November 15, 2021, all individuals entering a Canadian site (including but not limited to employees, visitors, contractors and agency workers) must be fully vaccinated against COVID-19 in accordance with the current government requirements.  Further, all employees must maintain all future booster vaccines as approved and recommended by Health Canada.  Accommodation from these requirements for reasons pursuant to the Ontario Human Rights Code, or any other applicable law (most commonly for medical and/or religious reasons) will be reviewed and considered by Apotex.

 

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.