Quality Compliance Specialist

Location: Leiden, Netherlands

Duration: 12 months

Hours: 40 (hybrid, 3 days on site)

Imagine your next project as a Manufacturing GMP Specialist, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!  Biotherapeutics Operations is an operational department of Janssen Biologics in Leiden. Because of an increasing workload, the Compliance team of Biotherapeutics Operations wants to strengthen our GMP compliance culture and capabilities with an additional GMP Specialist.

roles and responsibilities

The Manufacturing GMP Specialist facilitates cGMP compliance within operations and is owner or coordinator of the relevant GMP processes like audits and inspections, annual product quality reviews, segregation and routing, periodic reviews, and quality risk assessments. Building a strong network within the organization will help to support and improve the GMP status of Operations.

As a GMP Specialist you will work continuously on a GMP compliant environment within Operations. Specific tasks for the GMP Specialist are:

• Leading operational inspection readiness (OIRT)

• Develop and/or improve GMP compliance processes and practices

• Advise operational departments on cGMP topics

• Coach / lead GMP/OIRT representatives on the shopfloor

• Perform GMP assessments within projects and changes

• Support with internal and external quality audits and inspections

• Give GMP training on GMP related topics

• Present periodically to the Operations Management Team

how to succeed

You will be an enthusiastic GMP Specialist who is ready for a new challenge! You will also bring:

• Bachelor or Master degree in Biotechnology, Biochemistry, Biopharma, Process

• Technology or equivalent.

• You have at least 4 years of work experience as a GMP or Compliance Specialist

• and are familiar with the cGMP guidelines like EudraLex - Volume 4 and ICH Q7, Q9, Q10.

• Excellent communication skills, written and verbal in English (required) and Dutch (pre).

• You are enthusiastic, independent, innovative (be able to think outside the box), stress resistant (be able to deal with pressure, fast changes) and you can transfer this to your team.

• Being a certified facilitator for performing quality risk assessments would be a benefit

benefits

This role offers a very competitive hourly rate. This contract will run for a 12 month and has a strong chance of extension. 

you are welcome here

Janssen is an innovative pharmaceutical company: we work every day on the frontline of health innovation. We can only meet this challenge because of our talented employees. Working at Janssen means that you get every opportunity to optimally develop your career.

about Janssen 

Janssen is the Pharmaceutical Company of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare Company. At Janssen, we bring together top scientists and researchers to pursue the most promising science and drive collaboration to create visionary medicines and healthcare solutions covering five priority therapeutic areas - Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, and Oncology. Contribute to the next pharmaceutical breakthrough with your next project at Janssen. 

https://www.janssen.com/netherlands/nl/janssen-nederland/vaccines-r%26d-leiden

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email.  

questions

If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.