Senior QA Associate-00000JPY
Description
We are currently recruiting for a :
Senior QA Associate
Responsibilities
In the area of release of clinical trial material, you are responsible for :
– Handling events/deviations related to the manufacturing/temperature excursions occurring during relabeling, distribution
– Documenting and reviewing temperature excursions and releasing the material at the clinical sites
– Close interaction with the Clinical Supply Chain P&L groups in order to ensure timely releases
– Perform the GMP release of relabeled IMP
– Close interaction with other QA groups in order to ensure release of compliant IMP
– Perform the regulatory compliance checks for IMP
– Ensuring communication with clients & affiliates on release status of Clinical Trial material
– Supplying all necessary documents/certification to internal & external clients
– Assist in complaint investigations related to the packaging process
– Reporting of Quality Trends to management and the client groups
– Providing advice regarding legislation and guidelines to client groups
Qualifications
– Master degree in Chemical/Pharmaceutical sciences
– At least 1 year of experience in a strongly regulated or GMP environment
– Experience with GMP and/or other directives is an asset
– Excellent verbal & written communication skills
– Fluent in Dutch & English
– Team player & flexible
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: Quality
Bron: Senior QA Associate Job (Beerse, BE)
