Job Description
The Training Specialist GMP Aseptic will design, facilitate and implement the GMP training system and training initiatives to support the aseptic manufacturing.
RESPONSIBILITIES:
Design, implement and maintain instructor-led and e-learning training programs to build and sustain the competence and capabilities for the Cell Therapy 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 the 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, facilitating continuous process improvements using Lean Principles.
Actively participation in investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.
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.
Always ensure audit readiness for both internal and external audits (HPRA, FDA, corporate, customer) regarding 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.
Participate fully in any cross-functional training initiatives.
Drive and promote corporate values within the workplace.
Actively foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
Ensure timely completion of all SOP, reading, training and assessment.
Other duties as required and directed by the Quality Head, Cell Therapy or other Officer appointed by the Board of Directors.
EDUCATIONAL REQUIREMENTS RELEVANT EXPERIENCE:
Degree in Science.
More than 4 years’ experience working in 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 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
Professional Coaching Qualification advantageous
Proficiency in Microsoft Office and job-related computer applications required
Report, standards, policy writing skills required
For further information on this GMP Aseptic Training Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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