Training Lead

Key purpose:

We are looking to hire a dynamic, passionate, confident, proactive and meticulous Training Lead to join a goal-oriented team.

Duties and responsibilities:

• 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.

Qualifications and experience:

• Tertiary Qualification in Microbiology/ Biotechnology/ Life Science/ Pharmacy or equivalent.
• 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
• Microbiology/ Biotechnology/ Life Science/ Pharmacy qualification
• Experience in Planning, Coordinating and Facilitating GMP training
• Experience in Developing GMP training module example Cleaning room and Microbiology training material in the pharmaceutical industry
• Experience in conducting Induction for new starters and site-wide GMP training example Production and Quality Control sterile training
• Experience in GMP Training Audits
• Leadership ( middle management role) ability to engage with stakeholders and coordinate a training program
• Strong people skills, and ability to engage in various "new" areas of the business