GMP Training Lead

A growing global leader in the development, delivery and commercialisation of cell therapies have a fantastic job opening for a GMP Training Lead at their base in Hertfordshire. This is a dynamic and innovative organisation who pride themselves on their passion and expertise in the medical field.

Job Responsibilities:

• Responsible for day to day management and development of a high performing GMP training team.
• Developing the manufacturing centre GMP Training and Development Technical Strategy
  Managing resources to maintain compliance to the GMP training plan, escalate risks as required.
• Leading collaborations with third parties, including academic institutions, representing the company and collaborating, to develop training programs in accordance with industry needs.
• Providing expert input and advice when developing and delivering technical training programmes for both aseptic manufacturing skills and QMS tools and techniques (e.g. root cause analysis).
• Responsible for day to day management and development of a high performing GMP training team.
• Liaise with the Head of HR and HR Manager - L&D Specialist to assess/identify soft skills training needs, as required.
  

Skills and Requirements:

• At least five years' experience in aseptic pharmaceutical manufacturing operations.
• Experience in interacting with the regulatory authorities.
• Knowledge of EU/MHRA regulatory environments, ideally experience of FDA regulatory requirements.
• Practical experience in establishing and/or improving site GMP training processes.
• Practical experience in performing training for GMP operations.
• Ideally, experience of working with quality processes such as deviations, change controls or corrective actions.
• Ideally, practical experience in aseptic pharmaceutical manufacturing, including performing gowning, cleaning and disinfection activities in compliance with EudraLex Vol 4, Annex 1.
• Highly motivated, pragmatic and practical to support the company's mission to accelerate the development of a commercial industry in the UK.
• Project ownership and pride in its delivery.
• Flexibility towards work assignments and new learning.
• Ability to manage multiple and varied tasks and prioritise workload with attention to detail.
• Good written and oral communication skills and presentation skills.
• Proven coaching ability.
• Experienced in training approaches, tools and techniques.
• Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives.
• Ability to quickly establish credibility and build rapport and trust.
• An understanding of adult learning principles.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Marjolene D'Almeida-Ayeni at 0203 854 2626 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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