Specialist, GMP Compliance & Training

Job Summary

Responsible for planning and execution of quality risk assessments on the shop floor in manufacturing, packaging and warehouse. Delivering annual GMP training program for personnel at the GTA sites in order to maintain a high level of compliance.

Job Responsibilities

1. GMP Training:

• Create, maintain, and deliver effective GMP and Compliance training programs and tools (e.g e-learning) customized for the GTA Sites.
• Monitor and enhance shop floor training programs to ensure compliance with internal standards and health authority regulations.
• 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.
• Monitor training gaps for assigned client groups and work with management to close gaps.

2. Continuous Compliance Improvements (CCI):

• 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.
• 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.
• Assist Compliance team at the site with preparation and execution of internal, regulatory and customer audit on the shop floor.
• Responsible for suggesting/evaluating changes to the system, working with departments outside QA to improve quality and compliance as related to the system.
• Create, maintain, analyse and report metrics enabling constant improvements to the training and audit program. Identify trends and patterns and make recommendations to management.
• Help define and implement processes supporting Audit execution, writing and updating.

3. Provide support, as  required in maintaining the GMP Training documentation in GLMS.
4. Set personal performance goals and provide input to departmental objectives.
5. Works in a safe manner collaborating as a team member to achieve all outcomes.
6. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
7. 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.
8. All other relevant duties as assigned.

Job Requirements

• Education: Bachelor of Science Degree (or equivalent) in a related discipline.
• Knowledge, Skills and Abilities:
  • 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.
  • Experience with Microsoft Computer Products (Word, Excel, Access, Project). Experience with SAP is an asset.
  • Must be able to work independently with minimal supervision.
  • Superior interpersonal skills and ability to work effectively in a team environment within and outside the department.
• Experience:

• At least 5 years’ experience in the pharmaceutical industry, in a QA or QC role.