For our client - a leading pharmaceutical company situated in Aesch BL - we are contracting a:
Prozess- und Reinigungsvalidierungs-Experte
-Based on existing process risk analyses and existing CMA, CPP and CQA, you coordinate the preparation of cleaning and process validation plans and reports for pharmaceutical API and in vitro diagnostics, in collaboration with production and quality control experts.
-In cooperation with the production and supply chain departments, you plan and schedule the execution of cleaning and process validations for pharmaceutical API and in vitro diagnostics. Based on statistical and risk-based models, you will develop and coordinate the creation of the corresponding sampling plans. You will train the employees for the implementation and monitor the validation activities.
-You will coordinate and support interdisciplinary process risk analyses with your specialist knowledge and extract the cleaning and process validation relevant factors and parameters.
-You have 5+ year experience in a relevant field in industry.
-You are familiar with state of the art GMP compliant process and cleaning validations of pharmaceutical API according to EU GMP Guide and ISO 13485 for in vitro diagnostic products.
-You are familiar with the requirements for GMP-compliant validation of production and cleaning processes and know how to transfer these into suitable validation specifications and statistically relevant sampling models by use of statistic tools.
-You have good German and English skills.
This multifaceted project provides the opportunity to apply and increase your expert knowledge in one of the largest pharmaceutical companies worldwide. To submit your complete CV including diplomas and references just use the button ‘Apply'. We are looking forward receiving your application today!