Website Catalent Pharma Solutions
The Compliance Training Specialist overall responsibility is critical to our patients. The specialist is the first in the development of qualitied cGMP professionals leading our journey in development and manufacturing of quality products and processes with patient safety in mind, executing with efficiency always. Quality, safety, and on-time delivery is a must to be successful in this role!
- Create enthusiasm to ensure end user participation
- Develop and deliver training presentations on pertinent topics to large groups of personnel on an as needed basis, including new employee orientation(onboarding), annual refresher training, remedial training and on as a needed basis to support the production schedule. Examples include, but are not limited to, current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), Aseptic Processing, Client Confidentiality Training.
- Provide strategic oversight of the training program and system.
- Conduct seminars, workshops, individual training sessions, etc.
- Prepare educational material, such as, module summaries, videos, etc.
- Maintain and Perform administrative activities in the electronic systems(Master Control and Learning Management System)to track required training records and monitor employee performance and response to training
- Manage CAPA(Corrective and Preventive Actions), deviations and observations.
- Analyze training needs and design training and performance support deliverables, including training approach, training curriculum, training materials/content, training effectiveness assessment, and plan to ensure sustainability
- Liaise with all department management at Catalent to determine training needs, establish training curriculums and assignments based upon work functions, and schedule training sessions.
- Experience supporting regulatory cGMP, ICH and EU compliance is a plus
- Strong MicrosoftSkills(especially PowerPoint and Excel)
- Strong, proven aptitude for learning new E-Systems preferred
- Strong experience with electronic systems as Trackwise,Master Control and (LMS) ComplianceWire
- Experience performing risk assessments and building training content a plus
- Strong knowledge and experience working under the requirements of Good Manufacturing Practices (GMPs) for pharmaceuticals and biologics
- Bachelor’s degree and 6+ years of experience within the biologic, pharmaceutical or medical device industry with successful participation on training initiatives and responsibilities for developing or delivering trainings
Company: Catalent Pharma Solutions
Vacancy Type: Full Time
Job Location: Baltimore, MD, US
Application Deadline: N/A