The Aseptic GMP Training Specialist will design, facilitate and implement the GMP training system as well as the training initiatives to support the aseptic manufacturing of a new biologic.
- Design, implement and maintain instructor-led and e-learning training programs to build and sustain the competence and capabilities for the Facility.
- Develop, evaluate and maintain training materials, learning methodologies, strategies and technologies including on the job training programs, job aids and visual aids.
- Conduct training needs assessments in conjunction with people managers across all functions.
- Ensure that training is documented appropriately to reflect training requirements/status of personnel utilising the learning management system.
- Ensure that training documents are written effectively using good instructional design principles and the timely revision and rollout of training.
- Schedule and facilitate training sessions and other training as deemed appropriate, to ensure business needs are met, whilst facilitating continuous process improvements using Lean Principles.
- The Aseptic GMP Training Specialist will actively participate in investigations and investigation reports and execution/development of change control.
- Participate in conducting training audits internally ensuring audit/inspection ready in relation to all training requirements and be the training point of contact for internally and externally audits
- Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
- Actively lead and support projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
- Develop and maintain excellent communication and collaboration between Training and all other functions.
- Ensure audit readiness at all times for both internal and external audits (HPRA, FDA, corporate, customer) with regard to training.
- Actively lead and support major projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
- Participate as required in global project teams relating to Training and wider quality activities.
- Degree in Science or another relevant field.
- 4 years’ experience working an aseptic environment in the pharmaceutical industry, preferably in a Biologics company
- Thorough knowledge of GMP and current FDA & EMEA regulation
- Knowledge and experience of Lean Laboratories is preferable
- Experience and/or a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting
- Knowledge, and ideally application, of industry standard learning methodologies, documentation systems and learning management systems
- Knowledge of instructional design principles and adult learning methodologies
- Proficiency in Microsoft Office and job-related computer applications required
- Report, standards, policy writing, presentation skills required
- The Aseptic GMP training specialist will have excellent communication, scheduling and time management skills while also showing great attention to detail.
Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.