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.
- Submit monthly reports and give feedback on the effectiveness of training.
- Implement 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 with Standard Operating Procedure requirements.
- Continuously improve 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.
- Experience in planning, coordinating and facilitating GMP training.
- Experience developing GMP training modules (e.g., cleaning room and microbiology training material in the pharmaceutical industry).
- Experience conducting induction for new starters and site‑wide GMP training (e.g., 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.