GMP Training Specialist

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GMP Training Specialist – London – Competitive Package

This role is critical in ensuring that all employees involved in GMP-regulated activities receive the highest standard of training to maintain compliance, product quality, and patient safety.

Key Responsibilities:

1. Develop, implement, and maintain a GMP training program tailored for ATMP manufacturing, ensuring compliance with regulatory standards.
2. Deliver engaging and effective GMP training sessions for new hires, operational teams, and senior staff.
3. Create and update training materials, SOPs, and competency assessments to reflect the latest regulatory changes and best practices.
4. Conduct training gap analyses to identify areas for improvement and ensure continuous enhancement of training programs.
5. Maintain accurate training records in compliance with regulatory expectations (MHRA, FDA, EMA).
6. Collaborate with QA, Manufacturing, and Regulatory teams to align training with quality and compliance objectives.
7. Prepare the organization for regulatory inspections, ensuring employees are audit-ready regarding GMP training compliance.
8. Support on-the-job training initiatives, working closely with team leaders and subject matter experts to reinforce best practices.

Requirements:

1. Experience in GMP training and compliance within a pharmaceutical or biotechnology environment, preferably in ATMPs, cell & gene therapy, or biologics.
2. Strong knowledge of GMP regulations (MHRA, FDA, EMA, ICH, Eudralex) and training best practices.
3. Excellent presentation, communication, and interpersonal skills, with the ability to engage diverse audiences.
4. Experience with Learning Management Systems (LMS) and electronic training records is a plus.
5. A proactive mindset, with strong attention to detail and organizational skills.

What is in it for you?

1. Be part of a groundbreaking biopharmaceutical company that is transforming patient care.
2. Work in a dynamic ATMP environment, contributing to cutting-edge therapies.
3. Competitive salary and benefits package, with opportunities for career growth.
4. A supportive and collaborative team culture.

Apply now and take the next step in your GMP training career with an exciting ATMP company!