Quality compliance specialist managing CAPA, risk assessments, SOPs, and cGMP systems. Supporting Grifols’ global plasma - derived medicines and transfusion healthcare operations.
About the role
- Quality compliance training specialist developing GXP and technical training programs for Grifols, a global healthcare company. Supporting pharmaceutical manufacturing, quality, validation and environmental safety objectives.
Responsibilities
- Identify, design, present and evaluate training and development needs supporting strategic business objectives.
- Apply the adult learning model, including needs assessment, design, delivery and evaluation.
- Lead technical training projects according to agendas, target plans, specifications and timelines.
- Present technical training project proposals to senior management.
- Design and deliver innovative quality and GXP training programs, including templates, job aids, assessments and checklists.
- Identify internal and external resources and maintain professional customer relationships.
- Create training modules independently or with subject matter experts.
- Deliver organization-wide curricula supporting HES, SAP and cGXP objectives.
- Provide compliance oversight for curriculum and training procedures.
- Lead technical training activities and support trainer selection, coaching, technical training and facilitation development.
- Design and develop instructor-led, computer-based, web-based and e-learning training.
- Manage training from initial planning through final summary, including costs and lessons learned.
- Coordinate and facilitate orientation for new employees and contractors.
- Communicate ongoing technical training information to the site.
- Update training modules based on business-unit and regulatory needs.
- Consult on technical training needs and track training effectiveness and performance improvement.
- Deliver results to stakeholders to support continuous improvement.
Requirements
- Minimum BS/BA degree and 3-5 years’ relevant training experience in a regulated environment, or equivalent combination of education and experience.
- Minimum four years’ training experience in the development, design and implementation of technical training courses.
- Strong technical knowledge in the pharmaceutical industry.
- Relevant training experience within the past 5 years.
- Proficiency with word processing, graphics programs, databases, presentation delivery programs, video, web-based CBT and e-learning.
- Demonstrated high levels of values and integrity.
- Ability to maintain positive relationships internally and externally.
- Ability to work independently and in a team.
- Strong oral and written communication skills and good interpersonal skills.
- Excellent computer skills with MS Office and Adobe Acrobat.
- Bilingual French and English preferred.
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