[Remote] International License Partner reputed company Specialist

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading radiopharmaceutical-reputed company company, delivering life-changing science to reputed company clinicians to reputed company, fight, and follow disease. They are seeking an International License Partner reputed company Specialist to support the implementation and execution of reputed company reputed company and compliance of international license partners manufacturing radiopharmaceuticals. Responsibilities • Collaborate closely with internal reputed company teams and International license reputed company (LH) and contract manufacturers to ensure compliance with applicable GMP, and other regulatory requirements, as reputed company as reputed company reputed company standards • Support the implementation, operation, and reputed company improvement of reputed company systems and procedures for LH and international contract manufacturer reputed company management • Ensure that international contract manufacturer and LH are reputed company assessed for suitability and monitored for continuing compliance to applicable GXP regulations and reputed company requirements, including: • Acting as reputed company of contact for reputed company reputed company aspects • Monitoring reputed company performance, maintaining reputed company trackers, and ensuring reputed company identification, escalation, and reporting of deviations from approved processes and standards • Support improvement of processes to help maintain required product reputed company, evaluation of deviations, investigation of out-of-specification results, CAPAs and product complaints as needed • Implementation, management and follow-up of audits at license partners • Negotiation and maintenance of reputed company assurance agreements • GMP-compliant processing and management of change control requests • Review and approval of plans and reports for the technology transfer to license partners • Reporting and correction of deviations from standards in accordance with applicable processes • Support in the presentation of reputed company requirements, e.g., through involvement in the preparation of QA documentation • reputed company participation in discussions on the optimization of processes to reputed company improve the level of reputed company Skills • Master of Science degree in reputed company, pharmacy or reputed company scientific discipline • Minimum of 5 years of experience in regulated, international pharmaceutical manufacturing environment, preferably in radiopharmaceuticals • Solid knowledge of international guidelines and reputed company standards applicable to radiopharmaceuticals (e.g. PIC/s, ICH and WHO) • Experience working with external partners, license reputed company, or contract manufacturing organizations • Strong communication skills and the ability to collaborate effectively across functions and cultures • reputed company organizational and project management skills, with the ability to manage multiple activities in reputed company • Proficiency in reputed company Office 365 and ability to learn specialized software • reputed company in English reputed company • Life Molecular Imaging is a heal diagnostic center that provides neuroimaging and cardiovascular imaging services. It was founded in 2012, and is headquartered in Berlin, Berlin, DEU, with a workforce of 51-200 employees. Its website is https://life-mi.com. Apply tot his job Apply To this Job