Coordinator, Global Quality Learning Operations

2 weeks ago

North York, Canada Apotex Inc. Full time

**About Apotex Inc.**

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

**Job Summary**:
Support the success of the Global Quality Learning Operations team with the following areas of expertise:

- Training record Audit reports
- Acts as a GLMS Super admin resource and coach for the site admins to promote the standardized use of Success Factors Global Learning Management System (GLMS)
- Assist with supporting regulatory audits
- Acts as a GLMS System Coordinator for key compliance initiatives and admin of system level configuration change controls
- Global Quality Systems review and drafting of proposed changes to Master Data, Standard Operating Procedures, Standard Documents and Training Plans and ensuring Master Data governance related to training records in GLMS

**Responsibilities**:

- Liaise with cross Site Item Content admins and Functions to ensure consistent, timely and accurate training records. Support implementation of quality strategic initiatives / projects and monitor status of key milestones.
- Prepare routine and ad hoc training audit reports, assesses trends to propose recommendations to management to drive improvements.
- Contribute to the development and enhancement of GLMS and CDS workflow process training
- Prepare and coordinate activities in support of regulatory inspections.
- Maintain GLMS through master data governance and procedures for system maintance administration of GLMS to comply with regulatory, learning standards and system requirements
- Supports business with \ related to Couse Description Summary process
- Supports periodic review of courses, GLMS master data discrepancies and reconciliation
- Monitor trends in the business, including audit observation related to training and recommend on procedure update requirements.
- Design & deliver GLMS training for Enterprise, including facilitation of knowledge transfer with GLMS admins.
- Responsible to update SOPs and Global System User Manuals(GSUM)
- Master Data Maintenance for GLMS (Curricula, Domains, Assignment Profiles), processing work orders related to granting GLMS admin role / permissions
- Support maintenance of Apouniversity & GLMS web page Evaluate training workflow utilized by business to ensure standard is followed and identify opportunities to streamline based on changing business needs.
- Generate specific GLMS reports including training history, Learning Needs, User Curricula status, Item status and audit trail reports Counsel business on data integrity relating to learning processes and documentation.
- Support the audit of GLMS master data with review of GLMS Data Governance standards
- Implement & support training supporting documents workflow in the business for standard electronic content storage of training supporting documents
- Works in a safe and collaborating manner with team members.
- 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.
- Use sound technical judgement in making decisions that affect the company people, products or operations.
- Perform all work in accordance with all established regulatory and compliance and safety requirements.
- Perform tasks as assigned by management to support and maintain the effectiveness of the quality system.
- All other relevant duties as assigned.

**Job Requirements**:

- Education- Bachelors or Masters degree from a recognized University in Business, Education or Adult Learning or equivalent
- Knowledge, Skills and Abilities- Sound working knowledge of cGMPs, ICH guidelines and requirements
- Detail-oriented with strong analytical, investigative and technical report-writing skills
- Proven effective interpersonal and organization skills for project coordination / management
- SAP and QMS TrackWise experience required
- Excellent ability to communicate, both verbally and in written form, in English
- Ability to operate in a dynamic, fast-paced environment with the ability to work effectively in ambiguous and extended hours environment.
- Detail-oriented with strong organizational skills and follow-through capabilities
- Experience- A minimum of two years of practical experience in regulatory compliance and quality in the Pharmaceutical Industry
- 3- 5 years experience in Learning Operations in Pharmaceutical industry
- Experience in maintenance of data in Learning Management System, SharePoint, MS Offi

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