Spécialiste, système qualité et conformité - Quality System and Compliance Specialist

GRIFOLS, S.A.•Montreal, QC

1d•Onsite

About The Position

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. The Quality Compliance Training Specialist identifies, designs, presents and evaluates training and development needs in support of strategic business objectives. Applies the adult learning model to implement technical training programs in support of strategic business objectives. Proactively identifies best practices for the advancement of training methodology, approach, and tools. Focus on of the following areas: Manufacturing, Quality, Maintenance and Engineering, Validation, and Environmental Safety Security.

Requirements

Minimum BS/BA degree and 3-5 years’ relevant training experience in a regulated environment, or equivalent combination of education and experience.
Must possess a minimum of four years’ training experience in the development, design and implementation of technical training courses along with strong technical knowledge in pharmaceutical industry.
Must be proficient with word processing, graphics programs, databases and presentation delivery programs including video, web-based CBT and e-learning.
Relevant training experience must have been within the past 5 years.
Demonstrated high levels of values and integrity.
Ability to maintain positive relationships both internally and externally
Must be able to work independently and in a team.
Strong oral and written communication skills and good interpersonal skills
Must have excellent computer skills with MS Office and Adobe Acrobat.
Bilingual (French and English preferred).

Responsibilities

Applies the Adult learning model to all designs which includes the needs assessment, design, delivery, and evaluation.
Leads projects with a developed agenda and target plan to ensure implementation meets the training design specifications and time lines. Presents technical training project proposals to Senior Management as required.
Designs and delivers innovative quality and GXP training programs, for applicable areas. Programs may include templates, job aids, assessments, and checklists as needed.
Identifies internal/external resources to meet site technical training needs. Builds and maintains professional relationships with internal/external customers.
Designs training modules by creating the content alone or in partnership with subject matter experts.
Delivers organizational-wide curriculum to support strategic objectives, e.g. HES, SAP, cGXP. Provide compliance oversight to support curriculum and training procedure requirements.
Provides leadership for technical training activities to ensure consistency and promote performance improvements.
Partners with management in the selection process, coaching, technical training, and facilitation skill development of On-The-Job and/or Group Technical Trainers.
Provides compliance oversight to support curriculum and training procedure requirements.
Designs and develop instructor-led and computer based training to meet business objectives.
Manage facility turnaround training aspects which includes initial planning through final summary, including costs and lessons learned.
Coordinates and facilitates Welcome Orientation for new employees and contractors.
Provides ongoing communication to the site regarding technical training to ensure all employees are informed.
Continues education of training knowledge by participating/presenting in professional forums and organizations which may include benchmarking activities.
Updates training modules as required by business units/regulators.
Serves as a consultant to dedicated areas in support of technical training needs.
Tracks and trends technical training effectiveness and performance improvement.
Delivers results to stakeholders to ensure continuous improvement of objectives.