QUALIFICATIONS NEEDED
- Tertiary Qualification in Microbiology / Biotechnology / Life Science / Pharmacy or equivalent
NECESSARY EXPERIENCE & INDUSTRY ACCREDITATION / KNOWLEDGE
- At least 6 years’ experience in the pharmaceutical / biotech manufacturing industry
- At least 3 years’ experience in a Training Management / Facilitation position
- Experience in quality management systems within a cGMP facility
KEY DUTIES & RESPONSIBILITIES OF THE ROLE
- Plan and coordinate GMP training activities and requirements according to project plans and site requirements
- Prepare, review and coordinate GMP training procedures, processes and systems
- Identify risks, investigate / troubleshoot cGMP non-compliance issues
- Notify relevant department manager regarding issues of non-conformance and recommend corrective actions
- Provide coaching on training requirements and GMP needs to Managers and site
- Provide technical support for drafting of GMP modules along with Subject Matter Experts
- Source training material from external vendors
- Develop GMP training templates and customize training material where required
- Submission of monthly reports and feedback on effectiveness of training
- Risk mitigation plans for staff who are not ‘licensed’ to perform their work functions due to failed assessments
- Ensure that all GMP training audits are successful in with Standard Operating Procedure requirements
- Continuous improvement of the training system in line with industry trends and cGMP
- Overall accountability for the Trackwise Training System
Should you meet all the requirements and wish to apply, please send your latest CV and motivation to