Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A leader in biotechnology since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology, and launched the biotechnology industry’s first blockbuster medicines. Today, as a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Objective – To provide QA guidance and support in the production area at Amgen Breda – To perform batch record review of batches assembled, packaged and labeled and contract manufacturers. – To establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person Position Specific tasks: – Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions. – Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations. – Review and approve batch production record data entries before production activities take place – Perform finished product checks during (commercial) production runs – Compile and review batch records for lots assembled, packaged and labeled and contract manufacturers in preparation for disposition by Qualified Person. – Act as author for operational SOP’s and Work Instructions – Review of operational SOP’s and Work Instructions – Review and approve class I Non Conformances – Initiate and own QA Non Conformances as needed. In this job you work in 3 shifts (including night shifts) – MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience. – Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations. – Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases. – Manufacturing and/or Quality analytical processes and operations. – Fluent in English language. Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A leader in biotechnology since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology, and launched the biotechnology industry’s first blockbuster medicines. Today, as a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Objective – To provide QA guidance and support in the production area at Amgen Breda- To perform batch record review of batches assembled, packaged and labeled and contract manufacturers. – To establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified PersonPosition Specific tasks:- Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions. – Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.- Review and approve batch production record data entries before production activities take place- Perform finished product checks during (commercial) production runs- Compile and review batch records for lots assembled, packaged and labeled and contract manufacturers in preparation for disposition by Qualified Person.- Act as author for operational SOP’s and Work Instructions- Review of operational SOP’s and Work Instructions- Review and approve class I Non Conformances- Initiate and own QA Non Conformances as needed.In this job you work in 3 shifts (including night shifts)- MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience. – Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.- Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.- Manufacturing and/or Quality analytical processes and operations.- Fluent in English language.