GMP Specialist Leiden

GMP Specialist

The Company
In business for over 130 years, our client is a global leader in health technology, voted 'Best Medical Technology Company” 2020. Their portfolio is wide-ranging, ranging from Household items to personal care items, all the way to hearing & breathing solutions. This company prides themselves on their purpose, which has never changed: to improve people's lives with meaningful innovations.
 
Role Description
As a 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.

Responsibilities
– Leading operational inspection readiness (OIRT).
–  Develop and or improve GMP compliance processes and practices.
–  Advise operational departments on cGMP topics
– 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 

Requirements
– Bachelor or master’s degree in biotechnology, Biochemistry, Biopharma, Process Technology or equivalent.
–  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.
– 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

Other Information
Are you ready and would like to apply for his position? Feel free to contact me or apply below.