Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits; Conduct internal audits to assess the compliance of AbbVie quality management
Responsible for all tasks and resources including cross functional co-ordination required to complete relevant QC microbiology activities within regulated environment in the required timeframe. Management of QC Microbiology team to carry out tasks.
It’s a critical role ensuring that products are manufactured and released in accordance with cGMPs and other applicable regulations by providing expertise, leadership and direction to site operations. Ensures that all business objectives are addressed
Provides guidance and oversight to internal and external project team members for the successful management of clinical operation activities in accordance with International Council on Harmonisation of Technical Requirements for Registration of