Vacature Manufacturing GMP Specialist

Bedrijfsomschrijving

Johnson & Johnson is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, talented and multi-scaled people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. 

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 their GMP compliance culture and capabilities with an additional GMP Specialist.

For Johnson & Johnson we are looking for a Manufacturing GMP Specialist! We are looking for someone who likes to interact with people, sees problems as opportunities and gets energized by improving operational compliance processes to ensure our operational processes stay cGMP compliant. If you want to support this team and are motivated for a new challenge, here’s your chance!

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

• Bachelor or Master degree in Biotechnology, Biochemistry, Biopharma, Process Technology or equivalent.
• You have at least 4 years of pharmaceutical work experience as a GMP or Compliance Specialist
• You 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).
• Being a certified facilitator for performing quality risk assessments would be a pre.

We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development.

• This concerns a secondment contract for one year via Yacht with an initial assignment for 12 months at Johnson & Johnson.
• This role can be performed by a freelancer (ZZP) as well.
• We will offer a competitive benefit package in line with the seniority of the position, with a salary between 4200 and 5200 euro gross per 4 week period (based on full-time employment). 
• Working full time is preferred (32 or 36 hours can be discussed).

Heb je interesse in deze vacature en wil je graag op deze functie solliciteren? Neem dan contact op met Yacht via melissa.burghardt@yacht.nl of Melissa Burghardt. Of bezoek hun website onbekend.