Vacature GMP Trainer

GMP Trainer

• Titel GMP Trainer
• Functie Quality
• Sub functie Quality Training
• Locatie Leiden, South Holland, Netherlands
• Gepost jan 15 2024
• Referentie 24W

Beschrijving

GMP Trainer

We are actively seeking a dedicated individual to join our team as a GMP Trainer. In this role, you will play a crucial part in supporting the site training program for new and existing employees. Developing and giving GMP Training using the latest training techniques, as well as participating in improvements projects related to GMP Training.
The candidate should be a good communicator with accompanied coaching and influencing skills, embrace Training within Industries (TWI) training methodology, a hard-working change agent, who should constantly maintain connection with internal partners to stay apace with customer needs. Ultimately, an outstanding Trainer who should be well organized and able to set priorities.
You will be based at the campus in Leiden, The Netherlands.
GMP Training department
The GMP Training team is a part of the Quality department and is responsible for crafting and delivering training programs that ensure employees and contractors are knowledgeable about Good Manufacturing Practices (GMP) regulations. The team also assesses training needs, evaluates training efficiency, and continuously improves training processes to support a culture of quality and regulatory compliance within the organization.
Most of the activities within the department focuses on supporting the site in developing, maintaining of GxP Training materials which support the GxP manufacturing, development and laboratory processes. Using a validated electronic learning management system, the training department processes all training creation, adjustment requests from departments for the Leiden biologics site.
The responsibilities & the impact You will have:
• Responsible for developing, maintaining and improving the site's GMP training program, ensuring that GMP training programs are effective and efficient, and Ensure compliance with all regulatory requirements particularly in relation to the pharmaceutical and J&J cGMP requirements.
• Develops and rolls out customer oriented Ongoing cGMP training courses, in close corporation with departmental trainers and HR and other relevant departments. Organizes and rolls out the Training schedule.
• Is a qualified GMP Trainer and supports other internal GMP trainers in their training activities. Trains and qualifies other trainers.
• Reports on JBV's performance, e.g. through metrics, to site management in the area of responsibility.
• Identifies and follows up continuous improvements, or corrective and preventative actions as a result of performance measures or compliance issues. Ensures that improvements are rolled out effectively in the organization.
• The jobholder assists during regulatory inspections and other GMP audits with respect to Training. This includes answering questions from the inspectors and following up on any training related follow-up actions.
• Maintains a good knowledge of GMP and regulatory requirements, for Training and other quality systems.
• Proactively collaborates closely together with users, the Global and Local eSystem owner, HR, QSDM and other departments to ensure effective roll out of the training program and system in the organization.
• Explore opportunities to introduce emerging technological solutions that can augment and enhance the induction and training program
• Developing systems to monitor quality of training and schedule adherence to metrics and to implement continuous improvement strategies.

Kwalificaties

Who you are:
• Bachelor's degree or equivalent experience in a relevant field such as Life Sciences, Information Technology, or Business Administration.
• Preferred to have experience and/or affinity with learning programs and principles in coaching, giving training to individuals and / or groups within the pharmaceutical industry or similar highly regulated environments.
• Understanding of Training and Document Management processes, systems, and regulations, including GxP, FDA, and other industry standards.
• Proficient in applying digital tools, software, and platforms to enhance training delivery, document creation, management, and tracking processes.
• Analytical skills with the ability to identify bottlenecks, inefficiencies, and opportunities for improvement.
• Excellent communication and presentation skills, analytical and didactic ability.
• Diligent approach with a passion for delivering high-quality results while ensuring compliance and accuracy.
• Proficient in Dutch and English.

If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals. We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life. You'll have an opportunity to work for a global market leader working in a dynamic and inspiring working environment with many opportunities to work on exciting projects and assignments. Examples of some of the benefits offered are:
• Flexible working arrangements with J&J Flex, enabling you to work from home.
• 36 holidays. Based on full-time employment and 20 statutory holidays + 16 non-statutory holidays.
• Global Parenteral Leave policy offering 12 weeks of leave (birth/parenteral, adoption/foster care and parenteral) at 100% pay to parents.
• and more
For more than 130 years, diversity, equity & inclusion (DEI) are in our cultural fabric at Johnson & Johnson and woven into how we do business every day.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

Functie:	gmp trainer
Startdatum:	14-01-2024
Ervaring:	Ervaren
Educatielevel:	HBO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

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