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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.
- 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.
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.
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 from MHRA, FDA, and EMA. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and quality in the pharmaceutical industry.
✨Tip Number 2
Network with professionals in the GMP training field, especially those working in ATMPs or biologics. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in GMP training.
✨Tip Number 3
Prepare to discuss specific examples of how you've developed or delivered training programs in the past. Highlight any experience you have with Learning Management Systems (LMS) and how you've used them to enhance training effectiveness.
✨Tip Number 4
Showcase your communication and presentation skills by practising your delivery style. Consider conducting mock training sessions with friends or colleagues to refine 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 guidelines from MHRA, FDA, EMA, and ICH, as this knowledge will be crucial during your interview.
✨Showcase Your Training Experience
Prepare to discuss your previous experience in GMP training and compliance. Be ready to share specific examples of training programmes you've developed or delivered, and how they improved compliance and product quality.
✨Engage with Your Audience
Since the role involves delivering training sessions, demonstrate your presentation and communication skills during the interview. Practice engaging with your interviewers as if they were your trainees, showcasing your ability to connect with diverse audiences.
✨Highlight Your Proactive Mindset
Emphasise your proactive approach to identifying training gaps and improving training programmes. Share examples of how you've taken initiative in past roles to enhance training effectiveness and ensure compliance.
