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- Tasks: Develop and deliver engaging GMP training for new hires and teams.
- Company: Join a pioneering biopharmaceutical company transforming patient care.
- Benefits: Enjoy a competitive salary, career growth, and a supportive team culture.
- Why this job: Be part of cutting-edge therapies in a dynamic ATMP environment.
- Qualifications: Experience in GMP training within pharmaceuticals or biotechnology is essential.
- Other info: Collaborate with QA and regulatory teams to ensure compliance.
The predicted salary is between 36000 - 60000 £ per year.
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:
- Develop, implement, and maintain a GMP training program tailored for ATMP manufacturing, ensuring compliance with regulatory standards.
- Deliver engaging and effective GMP training sessions for new hires, operational teams, and senior staff.
- Create and update training materials, SOPs, and competency assessments to reflect the latest regulatory changes and best practices.
- Conduct training gap analyses to identify areas for improvement and ensure continuous enhancement of training programs.
- Maintain accurate training records in compliance with regulatory expectations (MHRA, FDA, EMA).
- Collaborate with QA, Manufacturing, and Regulatory teams to align training with quality and compliance objectives.
- Prepare the organization for regulatory inspections, ensuring employees are audit-ready regarding GMP training compliance.
- Support on-the-job training initiatives, working closely with team leaders and subject matter experts to reinforce best practices.
Requirements:
- Experience in GMP training and compliance within a pharmaceutical or biotechnology environment, preferably in ATMPs, cell & gene therapy, or biologics.
- Strong knowledge of GMP regulations (MHRA, FDA, EMA, ICH, Eudralex) and training best practices.
- Excellent presentation, communication, and interpersonal skills, with the ability to engage diverse audiences.
- Experience with Learning 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 ATMP environment, 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!
GMP Training Specialist employer: BioTalent
Contact Detail:
BioTalent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land GMP Training Specialist
✨Tip Number 1
Familiarise yourself with the latest GMP regulations and guidelines, especially those related to ATMPs. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and quality.
✨Tip Number 2
Network with professionals in the pharmaceutical and biotechnology sectors, particularly those involved in GMP training. Attend industry events or webinars to connect with potential colleagues and learn about the latest trends in training practices.
✨Tip Number 3
Prepare to discuss specific examples of how you've developed or delivered training programs in the past. Highlight any experience with Learning Management Systems (LMS) and how you've used them to enhance training effectiveness.
✨Tip Number 4
Showcase your communication and presentation skills during the interview process. Consider preparing a short mock training session to demonstrate your ability to engage diverse audiences effectively.
We think you need these skills to ace GMP Training Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities of a GMP Training Specialist. Familiarise yourself with GMP regulations and the specific requirements mentioned in the job description.
Tailor Your CV: Highlight your relevant experience in GMP training and compliance, especially within pharmaceutical or biotechnology environments. Use keywords from the job description to ensure your CV aligns with what the company is looking for.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for GMP training and your understanding of ATMP manufacturing. Mention specific experiences that demonstrate your ability to deliver effective training and maintain compliance.
Showcase Your Skills: In your application, emphasise your presentation, communication, and interpersonal skills. Provide examples of how you've engaged diverse audiences in previous training sessions or roles.
How to prepare for a job interview at BioTalent
✨Know Your GMP Regulations
Make sure you have a solid understanding of GMP regulations, especially those relevant to ATMPs, cell & gene therapy, and biologics. Brush up on the latest updates from MHRA, FDA, EMA, and ICH to demonstrate your expertise during the interview.
✨Showcase Your Training Experience
Prepare to discuss your previous experience in developing and delivering GMP training programs. Be ready to share specific examples of how you've engaged diverse audiences and improved training outcomes in your past roles.
✨Highlight Your Collaboration Skills
This role requires collaboration with various teams like QA, Manufacturing, and Regulatory. Think of examples where you've successfully worked with cross-functional teams to align training with compliance objectives and how that contributed to overall success.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills and ability to conduct training gap analyses. Prepare to discuss how you would identify areas for improvement in training programmes and implement effective solutions.
