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Quality Assurance & Control: Oversee testing of raw materials, manufacturing quality control, and product validation; Team Leadership: Manage and lead a team responsible for compliance and quality oversight; Regulatory Compliance Ensure adherence to
Ensuring strategic support is provided to Global Project Team (GPT) assignments and wherever necessary, takes the lead in ensuring procedural documents relevant to GPT as applicable, to relevant GxPs and capture the right level of regulatory importance.
Responsible for both Chemistry and Microbiology Lab Assets, ensuring that the Lab is advanced in its technologies while ensuring compliance and best practices are adhered to. The role ensures efficient and innovative technologies and ideas are being
He/She will support the QA program to assure the accuracy and quality of scientific data submitted to regulatory agencies in support of new drug applications and/or biological licensing agreement applications. The R&D QA Manager will collaborate and
Takes responsibility for oversight and monitoring of the system for collection, processing, reconciliation and reporting of ICSRs for the DSE region. This includes ensuring ICSR report intake, case processing, workflow monitoring, follow-up requests,