GMP Trainer

Janssen Biologics B.V.
  • Leiden
  • Vast
  • HBO, WO
  • 40 uur
  • Thuiswerken mogelijk
Apurva Inglekar avatar
Apurva Inglekar recruitment consultant

Yacht Life Sciences has a vacancy for a compliance GMP Trainer for the Quality Assurance GMP Training team of Janssen Biologics B.V. in Leiden.

We are looking for a dedicated individual to join the GMP Training team as a cGMP Trainer. The main responsibilities for the Trainer are developing GMP training using the latest techniques. Giving of these GMP Training items to new and existing employees.

You are responsible for record keeping and traceability of training documentation including schedule commitments and metrics reporting. In addition, you are responsible for responding, participating in improvement projects related to GMP training.

To be successful as a GMP Trainer, you should demonstrate strong coaching and communication skills, attention to details and embrace TWI (Training Within Industries) training methodology. Ultimately, an outstanding Trainer who should be well organized and able to set priorities.

Your key responsibilities are:

  • 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.
  • Maintains the electronic Training System and supports the users of this system. Ensures that the systems are fit-for-use and effectively rolled out in the organization.
  • 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.

Functie-eisen

  • MBO/HBO or Bachelor or equivalent in (analytical) chemistry, biotechnology, microbiology or technical or business sciences
  • You have at least 5 years’ experience in a pharmaceutical or highly regulated industry, preferably in a training, quality or compliance function.
  • 2 years’ experience with training
  • Proficient in Dutch and English

Competenties

  • You are a hard-working team member who has shown affinity with learning programs and principles
  • You have excellent communication and presentation skills, analytical and didactic ability
  • You are an extraordinary teammate with an end-to-end, customer centric mentality
  • You can connect easily at all levels in the organization

Arbeidsvoorwaarden

This concerns a direct contract at Janssen Biologics (J&J) for 1 year. Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed. They will offer a competitive benefits package in line with the seniority of the position (salary between 3200 and 4400 euro gross per month).

Bedrijfsinformatie

Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.

Solliciteren

Inclusiviteit en diversiteit

Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.

Apurva Inglekar avatar
Apurva Inglekar recruitment consultant

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recruiter Apurva Inglekar

Apurva Inglekar

recruitment consultant

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