GMP Training Officer

National Bioproducts Institute NPC has a vacancy for the role of GMP Training Officer.

The successful incumbent will be responsible for:

• Must possess knowledge of adult learning theory, instructional design and effective training methodologies. Computer literacy (MS Office, Visio, SAP, Internet).
• Minimum of 5 years' experience in a pharmaceutical manufacturing or quality assurance environment, with working knowledge of cGMP, pharmaceutical facilities, processes, equipment and systems.
• At least 2 years' experience in a Training role.
• Post Basic PMA preferred.

Applications are invited from suitably qualified and experienced candidates.

• Design a framework for implementation and maintenance of a competency-based cGMP training program at NBI.
• Identify cGMP training needs in Manufacturing (Operational departments) and other areas through detailed task analysis, appraisals and consultations.
• Collaborate with the CAPA Officer, Internal Auditor and compliance team to identify cGMP gaps and design training accordingly.
• Collaborate with subject matter experts to prepare and update training modules and materials for cGMP competencies.
• Ensure that the cGMP training matrix for each department is appropriate and adequate and in line with the departmental functions.
• Develop an appropriate cGMP module for induction of new staff.
• Provide guidance and inputs to managers and document compilers when drafting cGMP competency assessment questionnaires.
• Keep up to date with developments and methodologies in workplace learning and training by reading relevant journals, standards and guidelines, attending meetings and courses.
• Understand and apply e-learning techniques, and where relevant, be involved in the creation and/or delivery of e-learning packages.

• Amend and revise programmes and training content as necessary, in order to adapt to changes occurring in the work and regulatory environment.
• Consult and collaborate with department supervisors and managers to devise an appropriate training schedule that meets the training requirement with minimal impact to routine operations.
• Collaborate with the Learning, Development and Performance Management Division to schedule training events and to ensure personnel training records are up to date.
• Collaborate with the qualified trainers to execute cGMP training in line with the set schedule. Provide or facilitate training in conjunction with the qualified trainers.
• Monitor and review the progress of trainees using assessment tools relevant to each of the competencies.
• Follow up with personnel in case assessments were not successfully completed.
• Manage the competency assessment program, using tools such as Skillogical.
• Manage the training records, in line with current NBI practice and in collaboration with the Learning and Development Team.
• Maintain Training Curricula and training records in an inspection ready state.
• Evaluate effectiveness of GMP training.
• Provide statistics and frequent reports on cGMP training and the levels of competency, as inputs to quarterly and annual quality management review meetings.
• Maintain applicable administration procedures, policies and reports to ensure compliance with process and regulatory requirements.

• Promote and execute the Quality Policy throughout NBI.
• Promote cGMP Training throughout NBI.
• Attend and participate in routine meetings as required.
• Participate in Quality and GMP initiatives.
• Training of QA systems.