GMP Training Specialist – London – Competitive Package
This role is critical in ensuring that all employees involved inGMP-regulated activitiesreceive the highest standard of training to maintain compliance, product quality, and patient safety.
Key Responsibilities
* Develop, implement, and maintain aGMP training programtailored for ATMP manufacturing, ensuring compliance with regulatory standards.
* Deliver engaging and effectiveGMP training sessionsfor new hires, operational teams, and senior staff.
* Create and updatetraining materials, SOPs, and competency assessmentsto reflect the latest regulatory changes and best practices.
* Conducttraining gap analysesto identify areas for improvement and ensure continuous enhancement of training programs.
* Maintain accuratetraining recordsin compliance with regulatory expectations (MHRA, FDA, EMA).
* Collaborate withQA, Manufacturing, and Regulatory teamsto align training with quality and compliance objectives.
* Prepare the organization forregulatory inspections, ensuring employees are audit-ready regarding GMP training compliance.
* Supporton-the-job training initiatives, working closely with team leaders and subject matter experts to reinforce best practices.
Requirements
* Experience inGMP training and compliancewithin apharmaceutical or biotechnologyenvironment, preferably inATMPs, cell & gene therapy, or biologics.
* Strong knowledge ofGMP regulations(MHRA, FDA, EMA, ICH, Eudralex) and training best practices.
* Excellent presentation, communication, and interpersonal skills, with the ability to engage diverse audiences.
* Experience withLearning Management Systems (LMS)and electronic training records is a plus.
* A proactive mindset, with strong attention to detail and organizational skills.
What is in it for you?
* Be part of a groundbreaking biopharmaceutical company that is transforming patient care.
* Work in a dynamic ATMPenvironment, contributing to cutting-edge therapies.
* Competitive salary and benefits package, with opportunities for career growth.
* A supportive and collaborative team culture.
Apply now
and take the next step in your GMP training career with an exciting ATMP company!
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