- 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.
- 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.
- 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.
GMP Trainer - City Of London - BioTalent Ltd
BioTalent Ltd City Of London
1 week ago
Description
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
Requirements
What is in it for you?
Apply now
and take the next step in your GMP training career with an exciting ATMP company
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