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Training Officer

7 months ago

Cape Town, South Africa Biovac Full time

**BIOVAC** is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive, and meticulous Training Officer to join a goal-oriented team.


**QUALIFICATIONS NEEDED**:

- Bachelors degree in biotechnology, Pharmacy, Biological Sciences, Chemistry, or a similar field.

**NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**:

- Between 3-5 years of experience in a sterile pharmaceutical/ biotech manufacturing industry.
- At least 2-3 Years experience in the creation and training of modules to site.
- Experience as a GMP Training Specialist or similar role within the pharmaceutical or biotech industry, with a focus on sterile manufacturing
- In-depth knowledge of GMP principles, regulations (e.g., PIC/S, FDA, EMA), and industry standards applicable to sterile pharmaceutical production
- Instructional design skills and experience in developing and delivering training materials for diverse audiences.
- Excellent presentation and communication skills, both written and verbal.

**KEY DUTIES & RESPONSIBILITIES OF THE ROLE**:

- Create engaging and interactive training materials, presentations, e-learning modules, and SOPs (Standard Operating Procedures) to effectively communicate GMP principles, sterile processing techniques, and best practices.
- Conduct engaging and informative GMP training sessions for new hires, existing employees, and temporary staff in various departments involved in sterile pharmaceutical manufacturing.
- Utilize a variety of training methods, including classroom-style sessions, hands-on practical exercises, and virtual training, to accommodate different learning styles and preferences.
- Develop and execute Quality related Training modules, such as eQMS Trackwise modules, Root cause analysis, Human error analysis, risk assessment, and Audit behaviour training.
- Develop training material to reduce deviation trends and prevent human error-related incidences.
- Develop training material to prevent the recurrence of audit-related observations.
- Regularly assess the effectiveness of GMP training programs through evaluations, quizzes, and performance metrics, and provide feedback to trainees and management as necessary.
- Monitor the compliance of employees with GMP regulations and identify areas for improvement, providing additional support and training where needed.
- Collaborate with cross-functional teams, including Sterility Support, Quality Assurance, Regulatory Affairs, and Production to design a robust GMP training curriculum tailored to the needs of different job roles and experience levels.
- Monitor training effectiveness and adjust delivery methods as needed to ensure maximum comprehension and retention of GMP concepts.
- Track and maintain comprehensive training records for all personnel to ensure compliance with GMP requirements and regulatory standards.
- Periodically review and update training materials to align with changing regulations, industry best practices, and internal process improvements.
- Collaborate with Quality Assurance teams to conduct audits and inspections related to training records and identify areas for improvement.
- Stay up to date with industry trends, new technologies, and advancements in GMP regulations to enhance the effectiveness and relevance of the training program.
- Analyse training metrics and feedback to identify areas of improvement, implement corrective actions, and develop strategies for enhancing training efficiency and effectiveness.
- Stay current with relevant regulatory guidelines, industry trends, and best practices related to sterile pharmaceutical GMP.
- Translate regulatory updates into actionable training materials and communicate changes to relevant stakeholders promptly.
- Proactively seek ways to optimize training delivery and engagement to ensure the highest level of learning retention.
- Write and update Training SOPs in line with the latest GMP guidance.
- Responsible for ensuring that the site training plan is coordinated, scheduled, and executed in line with cGMP requirements.
- Manage the Trackwise training module and drive continuous improvement initiatives of the e-learning system.
- Ensure all training aspects on site are documented and integrated within the Trackwise digital Training module.
- Prepare training metrics and monitor trends. Drive improvement where adverse trends are identified.
- Ensure that training audits are successful and in line with SOP and GMP requirements.
- Ensure that planned Induction, Job Specific, and GMP training is performed timeously.
- Ensure that all training modules and content are stored as required.
- Ensure training curriculums are in place for all staff.
- Participate in projects to continuously improve training on-site.
- Develop training approaches for new projects (e.g., New buildings/staff related) and ensure that all new processes and people are incorporated into the trai